Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Sponsor

Medtronic Cardiovascular (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02701283

Collaborator

(none)

2,223

Enrollment

Locations

Arms

120

Duration (Months)

25.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: Medtronic Transcatheter Aortic Valve Replacement Systems Device: Surgical Aortic Valve Replacement (SAVR)	N/A

Detailed Description

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

Study Design

Study Type:

Interventional

Actual Enrollment :

2223 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Device: Medtronic Transcatheter Aortic Valve Replacement Systems Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems
Active Comparator: Surgical Aortic Valve Replacement (SAVR) Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)	Device: Surgical Aortic Valve Replacement (SAVR) Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

Arm

Intervention/Treatment

Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems

Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Device: Medtronic Transcatheter Aortic Valve Replacement Systems

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

Active Comparator: Surgical Aortic Valve Replacement (SAVR)

Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)

Device: Surgical Aortic Valve Replacement (SAVR)

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

Outcome Measures

Primary Outcome Measures

Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study [Randomized Controlled Trial - 24 months Continued Access Study - 12 months]
Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).

Secondary Outcome Measures

RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days [30 days]
Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication
New Pacemaker Implantation at 30 Days [30 days]
The rate of new permanent pacemaker implant at 30 days
Prosthetic Valve Endocarditis at 1 Year [1 year]
The rate of prosthetic valve endocarditis at 1 year
Prosthetic Valve Thrombosis at 1 Year [1 year]
The rate of prosthetic valve thrombosis at 1 year
All Stroke (Disabling and Non-disabling) at 1 Year [1 year]
The rate of all stroke (disabling and non-disabling) at 1 year
Life-threatening Bleeding at 1 Year [1 year]
The rate of life-threatening bleeding at 1 year
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year [1 year]
The rate of valve-related dysfunction requiring repeat procedure at 1 year
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial [1 year]
Stenosis (moderate or severe) Any of the following: Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA <0.8 cm2 Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA ≥0.8 cm2, and DVI <0.25 Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA <0.8 cm2, and DVI <0.25 Regurgitation (moderate or severe) Any of the following: Moderate or Severe Total Regurgitation Moderate or Severe Paravalvular Regurgitation Moderate or Severe Transvalvular Regurgitation
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year [Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year]
Quality of life summary scores and change from baseline using the following measures: KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial [1 year]
The rate of repeat hospitalization for aortic valve disease at 1 year

Other Outcome Measures

Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial [1 year]
Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year [1 year]
Reporting of prosthetic valve hemodynamic performance by EOA
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial [1 year]
Quality of life summary scores and change from baseline using the following measures: EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial [1 year]
Reporting of NYHA classification at 1 year NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity Class I: Subjects with cardiac disease resulting in slight limitation of physical activity Class III: Subjects with cardiac disease resulting in marked limitation of physical activity Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year [1 year]
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Efficacy: Device Success Rate [Hospital discharge or 7 days post-procedure (whichever occurs first)]
Assessment of procedural effectiveness by meeting all of the following device success criteria: Absence of procedural mortality, AND Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Severe aortic stenosis, defined as follows:
For symptomatic patients:

Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

For asymptomatic patients:

Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.

Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:
aspirin or heparin (HIT/HITTS) and bivalirudin
ticlopidine and clopidogrel
Nitinol (titanium or nickel)
contrast media
Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
Ongoing sepsis, including active endocarditis.
Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
Gastrointestinal (GI) bleeding that would preclude anticoagulation.
Subject refuses a blood transfusion.
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
Currently participating in an investigational drug or another device trial (excluding registries).
Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
Need for emergency surgery for any reason.
Subject is pregnant or breast feeding.
Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
Pre-existing prosthetic heart valve in any position.
Severe mitral regurgitation amenable to surgical replacement or repair.
Severe tricuspid regurgitation amenable to surgical replacement or repair.
Moderate or severe mitral stenosis amenable to surgical replacement or repair.
Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
Prohibitive left ventricular outflow tract calcification.
Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
Aortic annulus diameter of <18 or >30 mm.
Significant aortopathy requiring ascending aortic replacement.

For transfemoral or transaxillary (subclavian) access:

Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abrazo Arizona Heart Hospital	Phoenix	Arizona	United States	85016
2	Scripps Memorial Hospital La Jolla	La Jolla	California	United States	92037
3	University of Southern California University Hospital	Los Angeles	California	United States	90033
4	El Camino Hospital	Mountain View	California	United States	64040
5	Mercy General Hospital	Sacramento	California	United States	95816
6	Los Robles Hospital & Medical Center	Thousand Oaks	California	United States	91360
7	University of Colorado Hospital	Aurora	Colorado	United States	80045
8	Yale New Haven Hospital	New Haven	Connecticut	United States	06520
9	Morton Plant Hospital	Clearwater	Florida	United States	33756
10	Delray Medical Center	Delray Beach	Florida	United States	33484
11	HealthPark Medical Center	Fort Myers	Florida	United States	33908
12	University of Miami Hospital	Miami	Florida	United States	33136
13	Tallahassee Research Institute, Inc.	Tallahassee	Florida	United States	32308
14	Piedmont Atlanta Hospital	Atlanta	Georgia	United States	30309
15	Loyola University Medical Center	Maywood	Illinois	United States	60153
16	Saint Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46290
17	Mercy Medical Center	Des Moines	Iowa	United States	50314
18	The University of Kansas Hospital	Kansas City	Kansas	United States	66160
19	Jewish Hospital	Louisville	Kentucky	United States	40202
20	Terrebonne General Medical Center	Houma	Louisiana	United States	70360
21	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
22	MedStar Union Memorial Hospital	Baltimore	Maryland	United States	21218
23	The Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
24	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
25	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
26	Baystate Medical Center	Springfield	Massachusetts	United States	01199
27	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
28	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
29	Spectrum Health Hospitals	Grand Rapids	Michigan	United States	49503
30	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
31	Mercy Hospital	Springfield	Missouri	United States	65806
32	Saint Francis Hospital	East Hills	New York	United States	11548
33	Saint Joseph's Hospital Health Center	Liverpool	New York	United States	13088
34	Northwell Health	Manhasset	New York	United States	11030
35	The Mount Sinai Hospital	New York	New York	United States	10029
36	Strong Memorial Hospital	Rochester	New York	United States	14642
37	Duke University Medical Center	Durham	North Carolina	United States	27710
38	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
39	Sanford Medical Center	Fargo	North Dakota	United States	58122
40	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
41	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
42	The Ohio State University	Columbus	Ohio	United States	43210
43	OhioHealth Riverside Methodist Hospital	Columbus	Ohio	United States	43214
44	Integris Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
45	Oregon Health Science University	Portland	Oregon	United States	97239
46	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
47	Geinsinger Medical Center	Danville	Pennsylvania	United States	17043
48	Pinnacle Health	Harrisburg	Pennsylvania	United States	17043
49	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania	United States	15232
50	Medical University of South Carolina	Charleston	South Carolina	United States	29425
51	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
52	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas	United States	75204
53	Baylor Saint Luke's Medical Center	Houston	Texas	United States	77030
54	Houston Methodist Hospital	Houston	Texas	United States	77030
55	Methodist Hospital San Antonio	San Antonio	Texas	United States	78229
56	University Hospital Salt Lake City Utah	Salt Lake City	Utah	United States	84132
57	The University of Vermont Medical Center	Burlington	Vermont	United States	05401
58	Saint Mary's Hospital	Richmond	Virginia	United States	23226
59	Paramount Heart	Winchester	Virginia	United States	22601
60	Swedish Medical Center	Seattle	Washington	United States	98124
61	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
62	Royal North Shore Hospital	St Leonards	New South Wales	Australia	2065
63	Monash Medical Centre	Clayton	Victoria	Australia	3168
64	The Alfred Hospital	Melbourne	Victoria	Australia	3004
65	Saint Vincent's Hospital Sydney	Darlinghurst		Australia	2010
66	Fiona Stanley Hospital (FSH)	Murdoch		Australia	6150
67	London Health Sciences Centre	London	Ontario	Canada	N6A 5A5
68	Toronto General Health Hospital	Toronto	Ontario	Canada	MSG2C4
69	Glen Royal Victoria (McGill)	Montréal	Quebec	Canada	H4A 3J1
70	Montreal Heart	Montréal		Canada	H1T 1C8
71	IUCPQ	Quebec		Canada	G1V 4G5
72	Sunnybrook Health Sciences Centre	Toronto		Canada
73	Centre Hospitalier Régional Universitaire de Lille	Lille		France	59000
74	L'Hôpital Privé Jacques Cartier Massy	Massy		France	91300
75	Clinique Pasteur	Toulouse		France	31300
76	Kokura Memorial Hospital	Kitakyushu	Fokuoka	Japan
77	Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido	Japan
78	Teikyo University Hospital	Tokyo	Itabashi-K	Japan
79	Shonan Kamakura General Hospital	Kamakura	Kanagawa	Japan
80	Sendai Kousei Hospital	Sendai	Miyagi	Japan
81	National Cerebral and Cardiovasclular Center	Suita	Osaka	Japan
82	Osaka University Hospital	Suita	Osaka	Japan
83	Sakakibara Heart Institute	Fuchu	Tokyo	Japan
84	Catharina Ziekenhuis	Eindhoven		Netherlands	5623
85	St. Antonius Hospital Nieuwegein	Nieuwegein		Netherlands	3435
86	Erasmus Medisch Centrum	Rotterdam		Netherlands	3015
87	Waikato Hospital	Hamilton		New Zealand

Sponsors and Collaborators

Medtronic Cardiovascular

Investigators

Principal Investigator: Michael Reardon, MD, The Methodist Hospital Research Institute
Principal Investigator: John K. Forrest, MD, Yale New Haven Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Medtronic Cardiovascular

ClinicalTrials.gov Identifier:

NCT02701283

Other Study ID Numbers:

10234430Doc

First Posted:

Mar 8, 2016

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Aortic Valve Stenosis

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	Randomized Controlled Trial - As Treated Continued Access Study - Attempted Implant

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Period Title: Overall Study
STARTED	737	741	745
As Treated (Attempted Implant)	730	684	745
Implanted	727	686	745
COMPLETED	668	579	724
NOT COMPLETED	69	162	21

Baseline Characteristics

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems	Total
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study	Total of all reporting groups
Overall Participants	730	684	745	2159
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	74.1 (5.8)	73.7 (5.9)	74.9 (5.9)	73.9 (5.9)
Sex: Female, Male (Count of Participants)
Female	266 36.4%	233 34.1%	246 33%	745 34.5%
Male	464 63.6%	451 65.9%	499 67%	1414 65.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	NA NaN	NA NaN	25 3.4%	NA NaN
Not Hispanic or Latino	NA NaN	NA NaN	705 94.6%	NA NaN
Unknown or Not Reported	NA NaN	NA NaN	15 2%	NA NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	NA NaN	NA NaN	3 0.4%	NA NaN
Asian	NA NaN	NA NaN	4 0.5%	NA NaN
Native Hawaiian or Other Pacific Islander	NA NaN	NA NaN	1 0.1%	NA NaN
Black or African American	NA NaN	NA NaN	15 2%	NA NaN
White	NA NaN	NA NaN	707 94.9%	NA NaN
More than one race	NA NaN	NA NaN	0 0%	NA NaN
Unknown or Not Reported	NA NaN	NA NaN	15 2%	NA NaN
Subject characteristic - subject age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	74.1 (5.8)	73.7 (5.9)	74.9 (5.9)	73.9 (5.9)
Subject characteristic - body surface area (m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m^2]	2.0 (0.2)	2.0 (0.2)	2.0 (0.2)	2.0 (0.2)
Subject characteristic - SYNTAX Score I, Randomized Controlled Trial (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	1.9 (3.7)	2.1 (3.9)	NA (NA)	2.0 (3.8)
Society of Thoracic Surgeons (STS) score (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	2.0 (0.7)	1.9 (0.7)	1.6 (0.6)	1.9 (0.7)
STS factors (Percent of participants) [Number]
STS Factors Diabetes	31.4 4.3%	30.7 4.5%	30.4 4.1%	31 1.4%
STS Factors Serum Creatinine >2 mg/dl	0.4 0.1%	0.1 0%	0.4 0.1%	0.3 0%
STS Factors Dialysis	0.0 0%	0.1 0%	NA NaN	0.1 0%
STS Factors Hypertension	84.8 11.6%	82.4 12%	85.0 11.4%	83.6 3.9%
STS Factors Endocarditis	0.0 0%	0.0 0%	0.0 0%	0.0 0%
STS Factors Chronic Lung Disease (COPD)	15.1 2.1%	18.0 2.6%	20.3 2.7%	16.5 0.8%
STS Factors Immunosuppressive Therapy	2.1 0.3%	1.0 0.1%	1.1 0.1%	1.6 0.1%
STS Factors Peripheral Arterial Disease	7.5 1%	8.2 1.2%	8.7 1.2%	7.8 0.4%
STS Factors Cerebrovascular Disease	10.1 1.4%	12.0 1.8%	2.0 0.3%	11.0 0.5%
STS Factors Previous CABG	2.5 0.3%	2.0 0.3%	2.6 0.3%	2.3 0.1%
STS Factors Previous Valve Surgery	0.0 0%	0.0 0%	0.0 0%	0.0 0%
STS Factors Previous PCI	14.1 1.9%	12.9 1.9%	18.3 2.5%	13.5 0.6%
STS Factors Previous MI	6.6 0.9%	4.8 0.7%	8.1 1.1%	5.7 0.3%
STS Factors Atrial Fibrillation/ Atrial Flutter	15.3 2.1%	14.4 2.1%	15.2 2%	14.8 0.7%
New York Heart Association Classification (Percent of participants) [Number]
NYHA I	10.4 1.4%	9.2 1.3%	7.2 1%	9.8 0.5%
NYHA II	64.7 8.9%	62.6 9.2%	64.5 8.7%	63.6 2.9%
NYHA III	24.8 3.4%	27.8 4.1%	27.7 3.7%	26.2 1.2%
NYHA IV	0.1 0%	0.4 0.1%	0.5 0.1%	0.3 0%
Subject heart conduction disturbances (Percent of participants) [Number]
Number [Percent of participants]	3.3 0.5%	3.8 0.6%	4.2 0.6%	3.5 0.2%
Modified Rankin Score (mRS), Randomized Controlled Trial (Percent of participants) [Number]
mRS 0	83.8 11.5%	85.0 12.4%	NA NaN	84.4 3.9%
mRS1	9.6 1.3%	8.1 1.2%	NA NaN	8.9 0.4%
mRS 2	5.6 0.8%	6.2 0.9%	NA NaN	5.9 0.3%
mRS 3	1.0 0.1%	0.7 0.1%	NA NaN	0.9 0%
mRS 4	0.0 0%	0.0 0%	NA NaN	0.0 0%
mRS 5	0.0 0%	0.0 0%	NA NaN	0.0 0%
mRS 6	0.0 0%	0.0 0%	NA NaN	0.0 0%
Mean aortic gradient (mmHG) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHG]	46.9 (12.2)	46.5 (12.2)	45.5 (12.5)	46.7 (12.2)
Max aortic valve velocity (m/sec) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m/sec]	4.4 (0.5)	4.4 (0.5)	4.3 (0.5)	4.4 (0.5)
Aortic valve area (AVA) (cm2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm2]	0.8 (0.2)	0.8 (0.2)	0.8 (0.2)	0.8 (0.2)
Left Ventricular Ejection Fraction (LVEF) (Percentage of blood ejected) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of blood ejected]	61.7 (7.9)	61.9 (7.7)	61.8 (8.0)	61.8 (7.8)

Outcome Measures

1. Primary Outcome

Title	Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study
Description	Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).
Time Frame	Randomized Controlled Trial - 24 months Continued Access Study - 12 months

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	4.3 0.6%	6.3 0.9%	5.7 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Randomized Controlled Trial - Medtronic TAVR Systems, Randomized Controlled Trial - SAVR
	Comments	Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled Trial
	Type of Statistical Test	Non-Inferiority
	Comments	Absolute non-inferiority margin was 0.06

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Posterior Median of the Difference
	Estimated Value	0.999
	Confidence Interval	(2-Sided) 95% to
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.

2. Secondary Outcome

Title	RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days
Description	Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
As treated set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Composite event	5.3 0.7%	10.8 1.6%	6.6 0.9%
Death	0.4 0.1%	1.2 0.2%	0.7 0.1%
Disabling stroke	0.4 0.1%	1.6 0.2%	NA NaN
Life-threatening or disabling bleed	2.5 0.3%	7.5 1.1%	3.4 0.5%
Major vascular complication	3.7 0.5%	3.1 0.5%	0.4 0.1%
AKI (II or III)	0.8 0.1%	2.8 0.4%	NA NaN
All Stroke	NA NaN	NA NaN	2.7 0.4%

3. Secondary Outcome

Title	New Pacemaker Implantation at 30 Days
Description	The rate of new permanent pacemaker implant at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	17.7 2.4%	6.3 0.9%	15.0 2%

4. Secondary Outcome

Title	Prosthetic Valve Endocarditis at 1 Year
Description	The rate of prosthetic valve endocarditis at 1 year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	0.1 0%	0.5 0.1%	0.4 0.1%

5. Secondary Outcome

Title	Prosthetic Valve Thrombosis at 1 Year
Description	The rate of prosthetic valve thrombosis at 1 year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	0.3 0%	0.2 0%	0.0 0%

6. Secondary Outcome

Title	All Stroke (Disabling and Non-disabling) at 1 Year
Description	The rate of all stroke (disabling and non-disabling) at 1 year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	4.3 0.6%	4.3 0.6%	3.6 0.5%

7. Secondary Outcome

Title	Life-threatening Bleeding at 1 Year
Description	The rate of life-threatening bleeding at 1 year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	3.6 0.5%	8.7 1.3%	3.8 0.5%

8. Secondary Outcome

Title	Valve-related Dysfunction Requiring Repeat Procedure at 1 Year
Description	The rate of valve-related dysfunction requiring repeat procedure at 1 year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
Number [Percent of participants (K-M rate)]	0.6 0.1%	0.4 0.1%	0.8 0.1%

9. Secondary Outcome

Title	Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial
Description	Stenosis (moderate or severe) Any of the following: Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA <0.8 cm2 Peak aortic velocity >4 m/s OR mean aortic gradient >40 mmHg, AND EOA ≥0.8 cm2, and DVI <0.25 Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA <0.8 cm2, and DVI <0.25 Regurgitation (moderate or severe) Any of the following: Moderate or Severe Total Regurgitation Moderate or Severe Paravalvular Regurgitation Moderate or Severe Transvalvular Regurgitation
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Implanted

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	727	686
Moderate or severe stenosis	0.2 0%	0.4 0.1%
Moderate or severe regurgitation	4.3 0.6%	1.3 0.2%

10. Secondary Outcome

Title	Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year
Description	Quality of life summary scores and change from baseline using the following measures: KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time Frame	Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Randomized Controlled Trial - SAVR	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	730	684	745
30 day KCCQ - Overall	88.6 (14.2)	78.7 (18.8)	NA (NA)
30 day change from baseline - Overall	20.0 (21.1)	9.2 (22.3)	NA (NA)
30 day KCCQ - Clinical	89.7 (13.4)	82.6 (16.9)	NA (NA)
30 day change from baseline - Clinical	15.4 (19.6)	7.5 (20.5)	NA (NA)
1 year KCCQ - Overall	90.6 (12.7)	90.5 (12.4)	91.1 (13.8)
1 year change from baseline - Overall	21.6 (20.6)	20.7 (20.3)	24.7 (22.8)
1 year KCCQ - Clinical	89.9 (13.4)	90.2 (12.8)	NA (NA)
1 year change from baseline - Clinical	15.3 (18.9)	14.8 (18.9)	NA (NA)

11. Secondary Outcome

Title	Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial
Description	The rate of repeat hospitalization for aortic valve disease at 1 year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
As treated set

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	730	684
Number [Percent of participants (K-M rate)]	3.5 0.5%	5.8 0.8%

12. Other Pre-specified Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial
Description	Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Implanted

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	727	686
None	39.4 5.4%	72.2 10.6%
Trace	23.5 3.2%	19.3 2.8%
Mild/Mild to Moderate	32.9 4.5%	7.2 1.1%
Moderate/Moderate to Severe	4.1 0.6%	1.3 0.2%
Severe	0.1 0%	0.0 0%

13. Other Pre-specified Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year
Description	Reporting of prosthetic valve hemodynamic performance by EOA
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Implanted

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	727	686
Mean (Standard Deviation) [cm2]	2.23 (0.63)	1.96 (0.57)

14. Other Pre-specified Outcome

Title	Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial
Description	Quality of life summary scores and change from baseline using the following measures: EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
As treated set

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	730	684
EQ-5D Index Score at 1 year	0.81 (0.21)	0.81 (0.19)
1 year change from baseline EQ-5D Index Score	0.09 (0.24)	0.08 (0.24)

15. Other Pre-specified Outcome

Title	New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial
Description	Reporting of NYHA classification at 1 year NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity Class I: Subjects with cardiac disease resulting in slight limitation of physical activity Class III: Subjects with cardiac disease resulting in marked limitation of physical activity Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
As treated set

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	730	684
NYHA Class I	80.6 11%	79.5 11.6%
NYHA Class II	15.8 2.2%	15.7 2.3%
NYHA Class III	1.1 0.2%	1.4 0.2%
NYHA Class IV	0.4 0.1%	0.3 0%
Died prior to visit	2.1 0.3%	3.0 0.4%

16. Other Pre-specified Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year
Description	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time Frame	1 year

Outcome Measure Data

Analysis Population Description
Implanted

Arm/Group Title	Medtronic TAVR Systems	SAVR
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	727	686
Mean (Standard Deviation) [mmHG]	8.74 (3.58)	11.27 (4.81)

17. Other Pre-specified Outcome

Title	Efficacy: Device Success Rate
Description	Assessment of procedural effectiveness by meeting all of the following device success criteria: Absence of procedural mortality, AND Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)
Time Frame	Hospital discharge or 7 days post-procedure (whichever occurs first)

Outcome Measure Data

Analysis Population Description
Randomized Controlled Trial - Implanted set. Per the Clinical Investigational Plan, the incidence estimate is provided for the TAVR group only. Continued Access Study - Attempted implant set.

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems	Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Measure Participants	727	745
Number (95% Confidence Interval) [Percent of participants]	85.3 11.7%	98.1 14.3%

Adverse Events

	Randomized Controlled Trial - Medtronic TAVR Systems		Randomized Controlled Trial - SAVR		Continued Access Study - Medtronic TAVR Systems
Time Frame	Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months.
Adverse Event Reporting Description	Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.

Arm/Group Title	Randomized Controlled Trial - Medtronic TAVR Systems		Randomized Controlled Trial - SAVR		Continued Access Study - Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial		Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial		Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/730 (3.4%)		29/684 (4.2%)		19/745 (2.6%)
Serious Adverse Events
	Randomized Controlled Trial - Medtronic TAVR Systems		Randomized Controlled Trial - SAVR		Continued Access Study - Medtronic TAVR Systems
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	459/730 (62.9%)		495/684 (72.4%)		429/745 (57.6%)
Blood and lymphatic system disorders
Anaemia	22/730 (3%)		60/684 (8.8%)		0/745 (0%)
Blood Loss Anaemia	1/730 (0.1%)		21/684 (3.1%)		0/745 (0%)
Coagulopathy	0/730 (0%)		7/684 (1%)		0/745 (0%)
Disseminated Intravascular Coagulation	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Heparin-Induced Thrombocytopenia	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Hypergammaglobulinaemia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Iron Deficiency Anaemia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Leukocytosis	1/730 (0.1%)		4/684 (0.6%)		0/745 (0%)
Thrombocytopenia	2/730 (0.3%)		27/684 (3.9%)		0/745 (0%)
Cardiac disorders
Acquired Cardiac Septal Defect	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Acute Coronary Syndrome	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Acute Left Ventricular Failure	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Acute Myocardial Infarction	8/730 (1.1%)		5/684 (0.7%)		4/745 (0.5%)
Angina Pectoris	2/730 (0.3%)		3/684 (0.4%)		0/745 (0%)
Angina Unstable	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Aortic Valve Calcification	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Aortic Valve Incompetence	6/730 (0.8%)		2/684 (0.3%)		0/745 (0%)
Aortic Valve Stenosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Arrhythmia	3/730 (0.4%)		1/684 (0.1%)		0/745 (0%)
Arteriospasm Coronary	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Atrial Fibrillation	38/730 (5.2%)		135/684 (19.7%)		12/745 (1.6%)
Atrial Flutter	6/730 (0.8%)		20/684 (2.9%)		0/745 (0%)
Atrial Tachycardia	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Atrial Thrombosis	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Atrioventricular Block	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Atrioventricular Block Complete	89/730 (12.2%)		36/684 (5.3%)		0/745 (0%)
Atrioventricular Block First Degree	12/730 (1.6%)		1/684 (0.1%)		0/745 (0%)
Atrioventricular Block Second Degree	13/730 (1.8%)		5/684 (0.7%)		0/745 (0%)
Atrioventricular Dissociation	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Bradycardia	9/730 (1.2%)		5/684 (0.7%)		0/745 (0%)
Bundle Branch Block Left	29/730 (4%)		3/684 (0.4%)		0/745 (0%)
Bundle Branch Block Right	3/730 (0.4%)		1/684 (0.1%)		0/745 (0%)
Cardiac Amyloidosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Cardiac Arrest	11/730 (1.5%)		11/684 (1.6%)		7/745 (0.9%)
Cardiac Failure	4/730 (0.5%)		5/684 (0.7%)		0/745 (0%)
Cardiac Failure Acute	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Cardiac Failure Chronic	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Cardiac Failure Congestive	16/730 (2.2%)		24/684 (3.5%)		0/745 (0%)
Cardiac Tamponade	1/730 (0.1%)		3/684 (0.4%)		0/745 (0%)
Cardio-Respiratory Arrest	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Cardiogenic Shock	4/730 (0.5%)		6/684 (0.9%)		0/745 (0%)
Cardiomyopathy	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Cardiopulmonary Failure	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Conduction Disorder	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Coronary Artery Disease	4/730 (0.5%)		3/684 (0.4%)		0/745 (0%)
Coronary Artery Dissection	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Coronary Artery Occlusion	6/730 (0.8%)		3/684 (0.4%)		0/745 (0%)
Coronary Ostial Stenosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Diastolic Dysfunction	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Dressler's Syndrome	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Extrasystoles	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Left Ventricular Dysfunction	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Left Ventricular Failure	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Left Ventricular Hypertrophy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Low Cardiac Output Syndrome	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Mitral Valve Incompetence	2/730 (0.3%)		3/684 (0.4%)		0/745 (0%)
Myocardial Haemorrhage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Myocardial Infarction	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Myocardial Ischaemia	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Nodal Rhythm	1/730 (0.1%)		4/684 (0.6%)		0/745 (0%)
Palpitations	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Paroxysmal Atrioventricular Block	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Pericardial Effusion	8/730 (1.1%)		9/684 (1.3%)		0/745 (0%)
Pericardial Haemorrhage	1/730 (0.1%)		5/684 (0.7%)		0/745 (0%)
Pericarditis	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Pleuropericarditis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Prosthetic Cardiac Valve Thrombosis	1/730 (0.1%)		3/684 (0.4%)		0/745 (0%)
Pulseless Electrical Activity	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Right Ventricular Dysfunction	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Sinus Arrest	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Sinus Bradycardia	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Sinus Node Dysfunction	10/730 (1.4%)		8/684 (1.2%)		0/745 (0%)
Supraventricular Tachycardia	2/730 (0.3%)		7/684 (1%)		0/745 (0%)
Tachyarrhythmia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Tachycardia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Tricuspid Valve Incompetence	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Ventricular Extrasystoles	2/730 (0.3%)		3/684 (0.4%)		0/745 (0%)
Ventricular Fibrillation	6/730 (0.8%)		6/684 (0.9%)		0/745 (0%)
Ventricular Tachycardia	9/730 (1.2%)		7/684 (1%)		0/745 (0%)
Coronary artery compression	0/730 (0%)		0/684 (0%)		1/745 (0.1%)
Congenital, familial and genetic disorders
Hypertrophic Cardiomyopathy	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Ear and labyrinth disorders
Meniere's Disease	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Vertigo	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Endocrine disorders
Adrenal Insufficiency	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Adrenal Mass	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Thyroid Mass	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Eye disorders
Blindness	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Cataract	8/730 (1.1%)		3/684 (0.4%)		0/745 (0%)
Cataract Nuclear	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Corneal Degeneration	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Macular Hole	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Macular Oedema	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Optic Ischaemic Neuropathy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Retinal Artery Occlusion	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Retinal Detachment	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Retinal Vein Occlusion	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ulcerative Keratitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Visual Impairment	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Vitreous Haemorrhage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Gastrointestinal disorders
Abdominal Distension	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Abdominal Hernia	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Abdominal Mass	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Abdominal Pain	4/730 (0.5%)		1/684 (0.1%)		0/745 (0%)
Abdominal Pain Upper	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Abdominal Wall Haematoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Acquired Oesophageal Web	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Appendiceal Mucocoele	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Barrett's Oesophagus	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Colitis	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Constipation	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Dental Caries	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Diarrhoea	3/730 (0.4%)		1/684 (0.1%)		0/745 (0%)
Diverticulum	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Diverticulum Intestinal	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Duodenal Ulcer	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Dyspepsia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Dysphagia	1/730 (0.1%)		6/684 (0.9%)		0/745 (0%)
Enterocolitis Haemorrhagic	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Faeces Discoloured	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Gastric Polyps	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Gastric Ulcer Haemorrhage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Gastrointestinal Angiectasia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Gastrointestinal Haemorrhage	11/730 (1.5%)		5/684 (0.7%)		1/745 (0.1%)
Gastrooesophageal Reflux Disease	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Gingival Bleeding	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Haematochezia	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Hiatus Hernia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ileus	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Impaired Gastric Emptying	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Incarcerated Inguinal Hernia	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Inguinal Hernia	6/730 (0.8%)		2/684 (0.3%)		0/745 (0%)
Intestinal Ischaemia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Intestinal Obstruction	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Intra-Abdominal Haemorrhage	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Large Intestinal Stenosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Large Intestine Perforation	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Large Intestine Polyp	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Lower Gastrointestinal Haemorrhage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Melaena	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Mesenteritis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Nausea	1/730 (0.1%)		5/684 (0.7%)		0/745 (0%)
Obstructive Pancreatitis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Oesophageal Motility Disorder	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Oesophageal Obstruction	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Oesophageal Ulcer	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Oesophagitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Pancreatitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Pancreatitis Acute	1/730 (0.1%)		4/684 (0.6%)		0/745 (0%)
Peptic Ulcer Haemorrhage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Rectal Haemorrhage	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Retroperitoneal Haematoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Retroperitoneal Haemorrhage	3/730 (0.4%)		0/684 (0%)		1/745 (0.1%)
Small Intestinal Obstruction	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Upper Gastrointestinal Haemorrhage	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Volvulus	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Vomiting	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
General disorders
Asthenia	0/730 (0%)		4/684 (0.6%)		0/745 (0%)
Chest Discomfort	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Chest Pain	11/730 (1.5%)		11/684 (1.6%)		0/745 (0%)
Critical Illness	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Death	2/730 (0.3%)		3/684 (0.4%)		19/745 (2.6%)
Device Embolisation	1/730 (0.1%)		0/684 (0%)		2/745 (0.3%)
Extravasation	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Fatigue	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Generalised Oedema	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Granuloma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hernia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Infusion Site Extravasation	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Multiple Organ Dysfunction Syndrome	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Non-Cardiac Chest Pain	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Oedema	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Oedema Peripheral	3/730 (0.4%)		1/684 (0.1%)		0/745 (0%)
Pain	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Pelvic Mass	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Polyp	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Puncture Site Haemorrhage	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Pyrexia	8/730 (1.1%)		6/684 (0.9%)		0/745 (0%)
Stent-Graft Endoleak	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Swelling	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Systemic Inflammatory Response Syndrome	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Vascular Stent Stenosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Complication associated with device	0/730 (0%)		0/684 (0%)		7/745 (0.9%)
Perforation	0/730 (0%)		0/684 (0%)		4/745 (0.5%)
Hepatobiliary disorders
Acute Hepatic Failure	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Bile Duct Stone	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Cholecystitis	1/730 (0.1%)		4/684 (0.6%)		0/745 (0%)
Cholecystitis Acute	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Cholecystitis Chronic	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Cholelithiasis	4/730 (0.5%)		5/684 (0.7%)		0/745 (0%)
Gallbladder Fistula	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hepatic Cirrhosis	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Hepatocellular Injury	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Ischaemic Hepatitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Immune system disorders
Drug Hypersensitivity	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hypersensitivity	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Infections and infestations
Acute Sinusitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Appendicitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Arthritis Bacterial	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Arthritis Infective	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Bacteraemia	3/730 (0.4%)		4/684 (0.6%)		0/745 (0%)
Bartholin's Abscess	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Biliary Sepsis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Brain Abscess	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Bronchitis	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Cardiac Valve Abscess	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Cellulitis	8/730 (1.1%)		10/684 (1.5%)		0/745 (0%)
Chronic Sinusitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Clostridium Difficile Infection	0/730 (0%)		4/684 (0.6%)		0/745 (0%)
Coccidioidomycosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Cystitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Device Related Infection	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Diverticulitis	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Endocarditis	3/730 (0.4%)		6/684 (0.9%)		3/745 (0.4%)
Enterococcal Infection	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Escherichia Bacteraemia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Gastroenteritis	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Groin Abscess	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Implant Site Infection	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Infection	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Influenza	5/730 (0.7%)		2/684 (0.3%)		0/745 (0%)
Lower Respiratory Tract Infection	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Lyme Disease	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Mediastinitis	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Meningitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Oral Candidiasis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Orchitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Osteomyelitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Osteomyelitis Bacterial	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Otitis Media	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Parotitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Periodontitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pneumonia	11/730 (1.5%)		28/684 (4.1%)		0/745 (0%)
Postoperative Wound Infection	0/730 (0%)		4/684 (0.6%)		0/745 (0%)
Pseudomonas Bronchitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pyelonephritis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Sepsis	8/730 (1.1%)		13/684 (1.9%)		0/745 (0%)
Septic Shock	1/730 (0.1%)		6/684 (0.9%)		0/745 (0%)
Sinusitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Skin Graft Infection	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Staphylococcal Bacteraemia	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Streptococcal Bacteraemia	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Upper Respiratory Tract Infection	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Urinary Tract Infection	16/730 (2.2%)		10/684 (1.5%)		0/745 (0%)
Urosepsis	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Vascular Access Site Infection	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Wound Infection	1/730 (0.1%)		4/684 (0.6%)		0/745 (0%)
Injury, poisoning and procedural complications
Anaemia Postoperative	1/730 (0.1%)		20/684 (2.9%)		0/745 (0%)
Ankle Fracture	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Aortic Injury	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Arterial Injury	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Cardiac Valve Rupture	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Central Nervous System Injury	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Cervical Vertebral Fracture	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Clavicle Fracture	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Compression Fracture	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Craniocerebral Injury	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Fall	4/730 (0.5%)		6/684 (0.9%)		0/745 (0%)
Femoral Neck Fracture	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Femur Fracture	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Foreign Body	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Foreign Body In Gastrointestinal Tract	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Heart Injury	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hip Fracture	8/730 (1.1%)		1/684 (0.1%)		0/745 (0%)
Humerus Fracture	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Incision Site Haemorrhage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Incision Site Pain	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Incisional Hernia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Injury	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Joint Injury	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Limb Injury	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Meniscus Injury	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Metaphyseal Corner Fracture	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Periprocedural Myocardial Infarction	1/730 (0.1%)		3/684 (0.4%)		0/745 (0%)
Phrenic Nerve Injury	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pneumothorax Traumatic	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Post Procedural Complication	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Post Procedural Fever	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Post Procedural Haematoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Post Procedural Haemorrhage	1/730 (0.1%)		6/684 (0.9%)		0/745 (0%)
Post Procedural Hypotension	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Postoperative Delirium	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Postoperative Hypertension	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Postoperative Respiratory Failure	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Postoperative Thoracic Procedure Complication	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Postpericardiotomy Syndrome	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Procedural Haemorrhage	1/730 (0.1%)		19/684 (2.8%)		0/745 (0%)
Procedural Hypotension	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Procedural Pneumothorax	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Radiation Proctitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Radiation Retinopathy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Radius Fracture	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Rib Fracture	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Seroma	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Skin Abrasion	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Skin Laceration	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Spinal Compression Fracture	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Spinal Fracture	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Subdural Haematoma	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Subdural Haemorrhage	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Suture Related Complication	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Toxicity To Various Agents	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ulna Fracture	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Upper Limb Fracture	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Urethral Injury	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Vascular Access Site Complication	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Vascular Access Site Dissection	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Vascular Access Site Haematoma	1/730 (0.1%)		0/684 (0%)		2/745 (0.3%)
Vascular Access Site Haemorrhage	1/730 (0.1%)		1/684 (0.1%)		7/745 (0.9%)
Vascular Graft Thrombosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Vascular Pseudoaneurysm	4/730 (0.5%)		2/684 (0.3%)		0/745 (0%)
Vasoplegia Syndrome	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Wound Dehiscence	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Wound Secretion	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Vascular procedure complication	0/730 (0%)		0/684 (0%)		23/745 (3.1%)
Investigations
Anticoagulation Drug Level Above Therapeutic	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Blood Creatinine Increased	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Blood Magnesium Decreased	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Brain Natriuretic Peptide Increased	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
C-Reactive Protein Increased	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Cardiac Output Decreased	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Computerised Tomogram Abnormal	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Echocardiogram Abnormal	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ejection Fraction Decreased	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Electrocardiogram Qrs Complex Prolonged	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Haemoglobin Decreased	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Heart Rate Irregular	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Liver Function Test Abnormal	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Mammogram Abnormal	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Occult Blood	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Red Blood Cell Analysis Abnormal	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Transvalvular Pressure Gradient Increased	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Troponin Increased	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Urine Output Decreased	0/730 (0%)		5/684 (0.7%)		0/745 (0%)
Vascular Resistance Systemic	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Wall Motion Score Index Abnormal	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Metabolism and nutrition disorders
Acidosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Body Fat Disorder	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Dehydration	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Electrolyte Imbalance	1/730 (0.1%)		5/684 (0.7%)		0/745 (0%)
Failure To Thrive	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Fluid Overload	5/730 (0.7%)		29/684 (4.2%)		0/745 (0%)
Gout	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Hyperglycaemia	0/730 (0%)		18/684 (2.6%)		0/745 (0%)
Hyperkalaemia	1/730 (0.1%)		5/684 (0.7%)		0/745 (0%)
Hypervolaemia	1/730 (0.1%)		10/684 (1.5%)		0/745 (0%)
Hypocalcaemia	2/730 (0.3%)		11/684 (1.6%)		0/745 (0%)
Hypoglycaemia	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Hypokalaemia	4/730 (0.5%)		6/684 (0.9%)		0/745 (0%)
Hypomagnesaemia	6/730 (0.8%)		11/684 (1.6%)		0/745 (0%)
Hyponatraemia	2/730 (0.3%)		6/684 (0.9%)		0/745 (0%)
Hypophosphataemia	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Hypovolaemia	2/730 (0.3%)		4/684 (0.6%)		0/745 (0%)
Lactic Acidosis	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Malnutrition	1/730 (0.1%)		3/684 (0.4%)		0/745 (0%)
Metabolic Acidosis	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Metabolic Alkalosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Type 2 Diabetes Mellitus	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Vitamin B12 Deficiency	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Arthritis	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Back Pain	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Chest Wall Haematoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Flank Pain	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Foot Deformity	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Groin Pain	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Haemarthrosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Intervertebral Disc Degeneration	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Intervertebral Disc Displacement	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Intervertebral Disc Protrusion	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Lumbar Spinal Stenosis	4/730 (0.5%)		0/684 (0%)		0/745 (0%)
Muscular Weakness	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Musculoskeletal Chest Pain	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Musculoskeletal Pain	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Myopathy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Neck Pain	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Osteoarthritis	16/730 (2.2%)		11/684 (1.6%)		0/745 (0%)
Pain In Extremity	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Polyarthritis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Polymyalgia Rheumatica	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Rhabdomyolysis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Rotator Cuff Syndrome	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Spinal Osteoarthritis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Spinal Stenosis	4/730 (0.5%)		4/684 (0.6%)		0/745 (0%)
Tendonitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Tenosynovitis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Trigger Finger	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Adenocarcinoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Adenocarcinoma Pancreas	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Adenoid Cystic Carcinoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Basal Cell Carcinoma	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Benign Lung Neoplasm	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Bladder Cancer	4/730 (0.5%)		0/684 (0%)		0/745 (0%)
Brain Neoplasm	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Breast Cancer	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Cervix Carcinoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Colon Adenoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Colon Cancer	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Colon Neoplasm	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Colorectal Adenocarcinoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Endometrial Cancer	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Gallbladder Cancer	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
High-Grade B-Cell Lymphoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Lung Adenocarcinoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Malignant Melanoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Malignant Neoplasm Of Renal Pelvis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Meningioma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Mesothelioma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Metastatic Neoplasm	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Myelodysplastic Syndrome	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Nasal Sinus Cancer	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Neoplasm Malignant	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Oesophageal Carcinoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ovarian Cancer	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pancreatic Carcinoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Prostate Cancer	4/730 (0.5%)		5/684 (0.7%)		0/745 (0%)
Prostate Cancer Metastatic	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Rectal Cancer	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Renal Cell Carcinoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Renal Oncocytoma	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Skin Cancer	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Squamous Cell Carcinoma	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Squamous Cell Carcinoma Of Lung	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Squamous Cell Carcinoma Of Skin	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Thyroid Cancer	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Transitional Cell Carcinoma	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Uterine Cancer	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Nervous system disorders
Altered State Of Consciousness	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Aphasia	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Brain Injury	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Brain Stem Stroke	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Carotid Artery Disease	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Carotid Artery Occlusion	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Carotid Artery Stenosis	5/730 (0.7%)		2/684 (0.3%)		0/745 (0%)
Carpal Tunnel Syndrome	5/730 (0.7%)		1/684 (0.1%)		0/745 (0%)
Cerebral Haematoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Cerebral Haemorrhage	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Cerebral Infarction	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Cerebral Small Vessel Ischaemic Disease	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Cerebrovascular Accident	19/730 (2.6%)		23/684 (3.4%)		4/745 (0.5%)
Cervical Radiculopathy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Dementia With Lewy Bodies	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Dizziness	5/730 (0.7%)		4/684 (0.6%)		0/745 (0%)
Dysarthria	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Embolic Stroke	2/730 (0.3%)		2/684 (0.3%)		0/745 (0%)
Encephalopathy	0/730 (0%)		7/684 (1%)		0/745 (0%)
Generalised Tonic-Clonic Seizure	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Haemorrhage Intracranial	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Headache	2/730 (0.3%)		3/684 (0.4%)		0/745 (0%)
Hemianopia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Hemiparesis	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Hydrocephalus	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Hypercapnic Coma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hypertensive Encephalopathy	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Hypoaesthesia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Hypokinesia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hypoxic-Ischaemic Encephalopathy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Intracranial Hypotension	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ischaemic Stroke	4/730 (0.5%)		3/684 (0.4%)		25/745 (3.4%)
Lumbar Radiculopathy	3/730 (0.4%)		1/684 (0.1%)		0/745 (0%)
Lumbosacral Radiculopathy	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Metabolic Encephalopathy	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Migraine	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Myelopathy	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Neuromyopathy	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Neuropathy Peripheral	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Paraesthesia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Postictal State	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Presyncope	1/730 (0.1%)		4/684 (0.6%)		0/745 (0%)
Seizure	2/730 (0.3%)		4/684 (0.6%)		0/745 (0%)
Subarachnoid Haemorrhage	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Syncope	18/730 (2.5%)		7/684 (1%)		0/745 (0%)
Tarsal Tunnel Syndrome	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Tension Headache	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Thalamic Infarction	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Transient Ischaemic Attack	12/730 (1.6%)		9/684 (1.3%)		5/745 (0.7%)
Trigeminal Neuralgia	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Vascular Dementia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Product Issues
Device Breakage	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Device Dislocation	3/730 (0.4%)		0/684 (0%)		1/745 (0.1%)
Device Failure	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Device Leakage	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Device Loosening	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Device Physical Property Issue	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Lead Dislodgement	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Thrombosis In Device	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Psychiatric disorders
Alcohol Withdrawal Syndrome	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Alcoholism	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Anxiety	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Completed Suicide	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Confusional State	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Delirium	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Delirium Tremens	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Depression	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Mental Status Changes	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Renal and urinary disorders
Acute Kidney Injury	12/730 (1.6%)		27/684 (3.9%)		0/745 (0%)
Bladder Mass	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Bladder Outlet Obstruction	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Calculus Bladder	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Dysuria	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Haematuria	9/730 (1.2%)		4/684 (0.6%)		0/745 (0%)
Hydronephrosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Nephrolithiasis	1/730 (0.1%)		3/684 (0.4%)		0/745 (0%)
Oliguria	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Polyuria	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Renal Cyst	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Renal Failure	5/730 (0.7%)		7/684 (1%)		0/745 (0%)
Subcapsular Renal Haematoma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Urethral Stenosis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Urinary Retention	11/730 (1.5%)		12/684 (1.8%)		0/745 (0%)
Urogenital haemorrhage	0/730 (0%)		0/684 (0%)		3/745 (0.4%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Endometrial Hyperplasia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Testicular Pain	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Vaginal Haemorrhage	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Acute Respiratory Failure	2/730 (0.3%)		8/684 (1.2%)		0/745 (0%)
Asthma	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Atelectasis	1/730 (0.1%)		7/684 (1%)		0/745 (0%)
Bronchospasm	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Chronic Obstructive Pulmonary Disease	6/730 (0.8%)		2/684 (0.3%)		0/745 (0%)
Dysphonia	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Dyspnoea	8/730 (1.1%)		4/684 (0.6%)		0/745 (0%)
Dyspnoea Exertional	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Epistaxis	3/730 (0.4%)		3/684 (0.4%)		0/745 (0%)
Haemothorax	1/730 (0.1%)		5/684 (0.7%)		0/745 (0%)
Hypoxia	2/730 (0.3%)		7/684 (1%)		0/745 (0%)
Idiopathic Pulmonary Fibrosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Lung Disorder	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Mediastinal Haemorrhage	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Pleural Effusion	7/730 (1%)		49/684 (7.2%)		0/745 (0%)
Pleurisy	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Pneumomediastinum	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pneumonia Aspiration	1/730 (0.1%)		3/684 (0.4%)		0/745 (0%)
Pneumothorax	5/730 (0.7%)		10/684 (1.5%)		0/745 (0%)
Pulmonary Congestion	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pulmonary Embolism	3/730 (0.4%)		4/684 (0.6%)		0/745 (0%)
Pulmonary Hypertension	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Pulmonary Mass	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Pulmonary Oedema	2/730 (0.3%)		4/684 (0.6%)		0/745 (0%)
Respiratory Acidosis	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Respiratory Failure	10/730 (1.4%)		27/684 (3.9%)		0/745 (0%)
Thoracic Haemorrhage	1/730 (0.1%)		2/684 (0.3%)		0/745 (0%)
Skin and subcutaneous tissue disorders
Angioedema	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Decubitus Ulcer	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Erythema	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ischaemic Skin Ulcer	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pemphigoid	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Pyoderma Gangrenosum	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Skin Ulcer	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Subcutaneous Emphysema	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Urticaria	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Surgical and medical procedures
Aneurysm Repair	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Ankle Operation	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Cardiac Pacemaker Insertion	1/730 (0.1%)		0/684 (0%)		110/745 (14.8%)
Carpal Tunnel Decompression	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Cataract Operation	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Coronary Endarterectomy	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Drain Removal	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Hernia Repair	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Hip Arthroplasty	3/730 (0.4%)		1/684 (0.1%)		0/745 (0%)
Hip Surgery	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Knee Arthroplasty	5/730 (0.7%)		2/684 (0.3%)		0/745 (0%)
Shoulder Arthroplasty	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Spinal Fusion Surgery	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Thoracic Cavity Drainage	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Toe Amputation	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Tooth Extraction	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Transurethral Bladder Resection	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Cardiac operation	0/730 (0%)		0/684 (0%)		5/745 (0.7%)
Dialysis	0/730 (0%)		0/684 (0%)		1/745 (0.1%)
Hospitalisation	0/730 (0%)		0/684 (0%)		102/745 (13.7%)
Implantable defibrillator insertion	0/730 (0%)		0/684 (0%)		11/745 (1.5%)
Medical device removal	0/730 (0%)		0/684 (0%)		15/745 (2%)
Percutaneous coronary intervention	0/730 (0%)		0/684 (0%)		6/745 (0.8%)
Surgery	0/730 (0%)		0/684 (0%)		6/745 (0.8%)
Vascular operation	0/730 (0%)		0/684 (0%)		23/745 (3.1%)
Vascular disorders
Angiopathy	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Aortic Aneurysm	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Aortic Arteriosclerosis	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Aortic Dissection	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Aortic Perforation	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Aortic Stenosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Aortic Thrombosis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Arterial Haemorrhage	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Arterial Occlusive Disease	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Arterial Thrombosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Arteriosclerosis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Artery Dissection	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Deep Vein Thrombosis	2/730 (0.3%)		5/684 (0.7%)		0/745 (0%)
Femoral Artery Aneurysm	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Femoral Artery Dissection	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Haematoma	7/730 (1%)		3/684 (0.4%)		0/745 (0%)
Haemodynamic Instability	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Haemorrhage	6/730 (0.8%)		4/684 (0.6%)		18/745 (2.4%)
Hypertension	13/730 (1.8%)		33/684 (4.8%)		0/745 (0%)
Hypertensive Crisis	1/730 (0.1%)		1/684 (0.1%)		0/745 (0%)
Hypertensive Urgency	3/730 (0.4%)		0/684 (0%)		0/745 (0%)
Hypotension	39/730 (5.3%)		38/684 (5.6%)		0/745 (0%)
Hypovolaemic Shock	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Intermittent Claudication	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Lymphorrhoea	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Orthostatic Hypotension	0/730 (0%)		10/684 (1.5%)		0/745 (0%)
Peripheral Arterial Occlusive Disease	3/730 (0.4%)		2/684 (0.3%)		0/745 (0%)
Peripheral Artery Dissection	5/730 (0.7%)		0/684 (0%)		0/745 (0%)
Peripheral Artery Occlusion	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Peripheral Artery Stenosis	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Peripheral Ischaemia	2/730 (0.3%)		0/684 (0%)		0/745 (0%)
Peripheral Venous Disease	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Phlebitis	1/730 (0.1%)		0/684 (0%)		0/745 (0%)
Shock	0/730 (0%)		3/684 (0.4%)		0/745 (0%)
Shock Haemorrhagic	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Thrombophlebitis	0/730 (0%)		2/684 (0.3%)		0/745 (0%)
Thrombosis	2/730 (0.3%)		1/684 (0.1%)		0/745 (0%)
Vasodilatation	0/730 (0%)		1/684 (0.1%)		0/745 (0%)
Aortic disorder	0/730 (0%)		0/684 (0%)		1/745 (0.1%)
Other (Not Including Serious) Adverse Events
	Randomized Controlled Trial - Medtronic TAVR Systems		Randomized Controlled Trial - SAVR		Continued Access Study - Medtronic TAVR Systems
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	474/730 (64.9%)		571/684 (83.5%)		0/745 (0%)
Blood and lymphatic system disorders
Anaemia	50/730 (6.8%)		145/684 (21.2%)		145/745 (19.5%)
Blood Loss Anaemia	0/730 (0%)		40/684 (5.8%)		40/745 (5.4%)
Leukocytosis	57/730 (7.8%)		163/684 (23.8%)		163/745 (21.9%)
Thrombocytopenia	56/730 (7.7%)		196/684 (28.7%)		196/745 (26.3%)
Cardiac disorders
Atrial Fibrillation	55/730 (7.5%)		151/684 (22.1%)		151/745 (20.3%)
Atrioventricular Block First Degree	115/730 (15.8%)		119/684 (17.4%)		119/745 (16%)
Bundle Branch Block Left	246/730 (33.7%)		141/684 (20.6%)		141/745 (18.9%)
Bundle Branch Block Right	0/730 (0%)		48/684 (7%)		48/745 (6.4%)
Pericardial Effusion	0/730 (0%)		37/684 (5.4%)		37/745 (5%)
General disorders
Chest Pain	38/730 (5.2%)		0/684 (0%)		0/745 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	0/730 (0%)		65/684 (9.5%)		65/745 (8.7%)
Hyponatraemia	0/730 (0%)		35/684 (5.1%)		35/745 (4.7%)
Nervous system disorders
Dizziness	65/730 (8.9%)		49/684 (7.2%)		49/745 (6.6%)
Renal and urinary disorders
Acute Kidney Injury	0/730 (0%)		54/684 (7.9%)		54/745 (7.2%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/730 (0%)		69/684 (10.1%)		69/745 (9.3%)
Dyspnoea	42/730 (5.8%)		0/684 (0%)		0/745 (0%)
Pleural Effusion	0/730 (0%)		109/684 (15.9%)		109/745 (14.6%)
Pneumothorax	0/730 (0%)		39/684 (5.7%)		39/745 (5.2%)
Vascular disorders
Hypertension	76/730 (10.4%)		62/684 (9.1%)		62/745 (8.3%)
Hypotension	0/730 (0%)		41/684 (6%)		41/745 (5.5%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) & won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) & its rights in patentable or copyrightable materials, & check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.

Results Point of Contact

Name/Title	Kristin Smith, Clinical Research Manager
Organization	Medtronic Structural Heart & Aortic Clinical Research & Medical Science
Phone	763-526-3095
Email	kristin.m.smith@medtronic.com

Responsible Party:

Medtronic Cardiovascular

ClinicalTrials.gov Identifier:

NCT02701283

Other Study ID Numbers:

10234430Doc

First Posted:

Mar 8, 2016

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Study Details

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Outcome Measures

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Secondary Outcome Measures

Other Outcome Measures

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Inclusion Criteria:

Exclusion Criteria:

For transfemoral or transaxillary (subclavian) access:

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Study Results

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Statistical Analysis 1

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

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Other (Not Including Serious) Adverse Events

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