MISSION: EDWARDS INTUITY Elite Valve System

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02907463
• Collaborator: (none)
• Enrollment: 280
• Locations: 23
• Duration (Months): 22
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease; Aortic Stenosis

Detailed Description

Aortic valve replacement with mechanical or biological heart valves is the treatment of choice for aortic valve stenosis. Over the past several years, life expectancy has increased in industrial nations, but this has been accompanied by a rising rate of elderly patients with multiple illnesses.

Aortic stenosis remains the most common cause of adult valvular heart disease, the prevalence increasing with age. Average survival of patients treated conservatively has historically been reported as 2-5 years from the onset of symptoms. More recent studies have confirmed the dismal prognosis of severe aortic stenosis. Advanced age, reduced left-ventricular ejection fraction, congestive heart failure and renal insufficiency appear to be independent predictors of reduced survival. Asymptomatic patients with very severe aortic stenosis also share a poor prognosis with a high event rate and a risk of rapid functional deterioration. Early surgery offers a therapeutic option to improve clinical outcomes via decreasing cardiac mortality and improving symptoms.

Bioprostheses offer several advantages over mechanical bioprostheses, the most important being freedom from anticoagulation with a low rate of thromboembolic accidents.

In response to clinical need and in support of advances in minimally invasive surgical approaches to conventional AVR, Edwards Lifesciences developed the EDWARDS INTUITY Elite Valve System to achieve clinical benefits by reducing cardiopulmonary bypass and cross clamp times, while facilitating a less invasive approach to aortic valve replacement.

The system includes the EDWARDS INTUITY Elite Valve System, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB; the valve is based on prior heart valve designs which have a long history of safety and effectiveness and have incorporated additional features designed to improve patient outcomes and safety.

With only 3 guiding sutures and secure balloon expandable frame, the EDWARDS INTUITY Elite Valve system is well suited for smaller incisions and tight access, with an emphasis on procedural efficiency within existing operating suite of the surgeon.

Study Design

• Study Type: Observational
• Actual Enrollment: 280 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Assessing Clinical Outcomes Using the EDWARDS INTUITY Elite Valve System in Isolated AVR Using Minimally InvaSive Surgery In a EurOpean Multi-ceNter, Active, Post-market Registry
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Outcome Measures

Primary Outcome Measures

1. Subject's Average Time Spent on Cardiopulmonary Cross Clamp [At time of surgery; an average of 1 hour]

   Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

Secondary Outcome Measures

1. Subject's Average Time Spent on Cardiopulmonary Bypass. [At time of surgery; an average of 1.5 hours]

   Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

2. Device Technical Success Rate [At time of surgery]

   The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.

3. First Attempt Success Rate [At time of surgery]

   The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.

4. Procedural Success [Day of procedure and events occurring within 10 days of procedure]

   Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.

5. Subject's Average Health Care Utilization [Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.]

   The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.

6. Subject's Average Mean Gradient Measurements Over Time. [Baseline, Discharge and 6 months]

   Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

7. Subject's Average Peak Gradients Measurements Over Time. [Baseline, Discharge and 6 months]

   Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

8. Subject's Average Effective Orifice Area (EOA) Measurements Over Time [Baseline, Discharge and 6 months]

   Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

9. Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time. [Discharge and 6 months]

   Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

10. Subject's Average Performance Index Measurements Over Time. [Baseline, Discharge and 6 months]

    Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time.

11. Subject's Average Cardiac Output Over Time [Baseline, Discharge and 6 months]

    The amount of blood the heart pumps through the circulatory system in a minute.

12. Subject's Average Cardiac Index [Discharge and 6 months]

    A measure of cardiac output per square meter of body surface area

13. Subject's Amount of Paravalvular Leak Over Time. [Discharge and 6 months]

    Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

14. Subject's Amount of Aortic Valvular Regurgitation Over Time. [Discharge and 6 Months]

    Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

Other Outcome Measures

1. Subject's Average SF-36 Physical Health Summary [Baseline and 6 months]

   The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.

2. Subject's Average SF-36 Mental Health Summary [Baseline and 6 months]

   The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.

3. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline [6 months compared to baseline]

   The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

4. Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time [Baseline and 6 months]

   The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

5. Subject's Average Fitness for Hospital Discharge [Day of surgical procedure through discharge from the hospital; an average of 7 days]

   Considered as the day at which the patient was fit for hospital discharge.

6. Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) [Events occurring within 30 days of procedure]

   Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

7. Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) [Events occuring >= 31 days and up through 6 months]

   Number of late adverse events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is 18 years or older

2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.

3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.

4. Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.

5. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.

6. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion Criteria:

1. Subject is diagnosed with pure aortic insufficiency.

2. Subject requires multiple valve replacement/repair

3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.

4. Subject has severe ventricular dysfunction defined as LVEF < 25%.

5. Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.

6. Subject has had an acute MI ≤ 3 months before the intended treatment.

7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.

8. Subject is oxygen or ventilator dependent.

9. Subject has life expectancy < 12 months.

10. Female subject is pregnant or lactating.

11. Subject with documented leukopenia (WBC < 3.5x 103/μL), anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.

12. Subject has renal insufficiency as determined by Serum creatinine

≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.

1. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.

2. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.

3. Aneurysm of the aortic root and/or ascending aorta

Intra-operative exclusion criteria:

1. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)

2. Subject has calcium on the anterior mitral leaflet which cannot be removed.

3. Subject has extensive calcification of the aortic root.

4. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.

5. The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.

6. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).

7. The device is not available in the correct size for the subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck	Innsbruck		Austria	6020
2	Klinisshe Abteiluing Für Herz-thoraxchirurgie	Vienna		Austria	1090
3	Aarhus Universitets Hospital Skejby	Aarhus N		Denmark	8200
4	CHU Bocage Central Dijon	Dijon		France	21074
5	Hôpital Cardiologique CHU Bordeaux Haut Leveque	Pessac Cedex		France	33 604
6	Herz- und Gefäß-Klinik GmbH Bad Neustadt	Bad Neustadt An Der Saale		Germany	97616
7	Universitätsklinikum der Ruhr-Universität Bochum Klinik für Herz- und Thoraxchirurgie	Bochum		Germany	44789
8	Herzzentrum Uniklinik Köln	Cologne		Germany	50924
9	Medizinische Hochschule Hannover	Hannover		Germany	30625
10	Herzzentrum Leipzig	Leipzig		Germany	04289
11	University Hospital Würzburg	Wurzburg		Germany	97080
12	G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation	Massa		Italy	54100
13	CentroCardiologico Monzino	Milan		Italy	20138
14	Clinica San Gaudenzio	Novara		Italy
15	Università Cattolica del Sacro Cuore Policlinico	Roma		Italy	00168
16	Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"	Udine		Italy	33100
17	Institut National de Chirurgie Cardiaque et Cardiologie Interventionnelle (INCCI)	Luxembourg		Luxembourg	1210
18	St Antonius Hospital	Nieuwegein		Netherlands	3430 EM / PO BOX 2500
19	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
20	Complexo Hospitalario Universitario A Coruna	La Coruna		Spain
21	Hospital Clínico San Carlos	Madrid		Spain	28040
22	Royal Infirmary Hospital Edinburgh	Edinburgh		United Kingdom	EH16 4SA
23	St Thomas' Hospital	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Christopher Young, MD FRCS, St. Thomas' Hospital
• Principal Investigator: Gunther Laufer, Prof. Dr. med, AKH Vienna Dep. of Cardiovascular Surgery

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Oct 12, 2016

More Information

Additional Information:

• New York Heart Association Classification
• EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02907463
• Other Study ID Numbers: 2015-05
• First Posted: Sep 20, 2016
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Edwards Lifesciences: Aortic Valve Replacement; Aortic Stenosis; EDWARDS INTUITY Elite; Rapid deployment valves
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Disease

Study Results

Participant Flow

Arm/Group Title	EDWARDS INTUITY Elite Valve System
Arm/Group Description	The system includes the EDWARDS INTUITY Elite Aortic Valve, Model 8300AB and the EDWARDS INTUITY Elite Delivery System, Model 8300DB.
Period Title: Overall Study
STARTED	280
Enrolled Cohort	280
Per Protocol Cohort	276
COMPLETED	243
NOT COMPLETED	37

Baseline Characteristics

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Overall Participants	276
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.7 (6.8)
Sex: Female, Male (Count of Participants)
Female	142 51.4%
Male	134 48.6%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Subject's Average Time Spent on Cardiopulmonary Cross Clamp
Description	Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.
Time Frame	At time of surgery; an average of 1 hour

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
Partial Sternotomy	49.9 (14.7)
Right Thoracotomy	65.2 (18.2)
All	51.9 (16.0)

2. Secondary Outcome

Title	Subject's Average Time Spent on Cardiopulmonary Bypass.
Description	Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Time Frame	At time of surgery; an average of 1.5 hours

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
Mean (Standard Deviation) [minutes]	79.0 (23.4)

3. Secondary Outcome

Title	Device Technical Success Rate
Description	The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.
Time Frame	At time of surgery

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.

Arm/Group Title	Enrolled Cohort
Arm/Group Description	A subject was considered enrolled into the registry when he/she signed the informed consent, and met all the registry eligibility criteria.
Measure Participants	280
Count of Participants [Participants]	276 100%

4. Secondary Outcome

Title	First Attempt Success Rate
Description	The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.
Time Frame	At time of surgery

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.

Arm/Group Title	Enrolled Cohort
Arm/Group Description	A subject was considered enrolled into the registry when he/she signed the informed consent, and met all the registry eligibility criteria.
Measure Participants	280
Count of Participants [Participants]	270 97.8%

5. Secondary Outcome

Title	Procedural Success
Description	Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.
Time Frame	Day of procedure and events occurring within 10 days of procedure

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.

Arm/Group Title	Enrolled Cohort
Arm/Group Description	A subject was considered enrolled into the registry when he/she signed the informed consent, and met all the registry eligibility criteria.
Measure Participants	280
Count of Participants [Participants]	274 99.3%

6. Secondary Outcome

Title	Subject's Average Health Care Utilization
Description	The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.
Time Frame	Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.

Arm/Group Title	Enrolled Cohort
Arm/Group Description	A subject was considered enrolled into the registry when he/she signed the informed consent, and met all the registry eligibility criteria.
Measure Participants	278
ICU Length of Stay	3.3 (7.2)
Hospital Length of Stay	9.5 (6.7)

7. Secondary Outcome

Title	Subject's Average Mean Gradient Measurements Over Time.
Description	Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Time Frame	Baseline, Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Baseline	50 (18.1)	46.6 (13.7)	44.5 (13.0)	45.3 (13.4)	45.1 (16.5)	46.0 (14.1)
Discharge	15.0 (5.6)	12.8 (5.0)	9.7 (3.4)	9.8 (3.6)	7.6 (3.0)	11.1 (4.7)
6 months	11.7 (4.4)	9.7 (3.4)	8.0 (3.7)	7.8 (2.6)	6.1 (2.9)	8.8 (3.7)

8. Secondary Outcome

Title	Subject's Average Peak Gradients Measurements Over Time.
Description	Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.
Time Frame	Baseline, Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Baseline	80.3 (25.9)	78.9 (22.8)	73.4 (20.8)	74.8 (20.9)	74.0 (22.0)	76.3 (22.1)
Discharge	28.0 (10.4)	25.0 (10.7)	18.4 (6.6)	18.6 (7.3)	15.3 (6.2)	21.4 (9.5)
6 months	23.6 (8.4)	19.7 (7.6)	15.7 (6.7)	15.0 (4.7)	12.6 (4.9)	17.5 (7.4)

9. Secondary Outcome

Title	Subject's Average Effective Orifice Area (EOA) Measurements Over Time
Description	Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Time Frame	Baseline, Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Baseline	0.7 (0.2)	0.8 (0.3)	0.8 (0.2)	0.9 (0.2)	1.0 (0.2)	0.8 (0.3)
Discharge	1.2 (0.3)	1.5 (0.6)	1.9 (0.6)	2.0 (0.6)	2.3 (0.7)	1.8 (0.6)
6 months	1.2 (0.3)	1.5 (0.4)	1.9 (0.5)	2.1 (0.5)	2.5 (0.6)	1.8 (0.6)

10. Secondary Outcome

Title	Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.
Description	Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.
Time Frame	Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Discharge	0.7 (0.2)	0.9 (0.4)	1.0 (0.3)	1.0 (0.3)	1.1 (0.4)	0.9 (0.3)
6 months	0.7 (0.1)	0.8 (0.2)	1.0 (0.3)	1.1 (0.3)	1.2 (0.3)	0.9 (0.3)

11. Secondary Outcome

Title	Subject's Average Performance Index Measurements Over Time.
Description	Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time.
Time Frame	Baseline, Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Baseline	0.5 (0.1)	0.5 (0.2)	0.4 (0.1)	0.4 (0.1)	0.4 (0.1)	0.5 (0.2)
Discharge	0.9 (0.2)	1.0 (0.4)	1.0 (0.3)	1.0 (0.3)	0.9 (0.3)	1.0 (0.3)
6 months	1.0 (0.2)	1.0 (0.2)	1.0 (0.3)	1.0 (0.2)	1.0 (0.2)	1.0 (0.2)

12. Secondary Outcome

Title	Subject's Average Cardiac Output Over Time
Description	The amount of blood the heart pumps through the circulatory system in a minute.
Time Frame	Baseline, Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Baseline	4.8 (1.2)	5.3 (1.5)	5.4 (1.3)	6.1 (1.8)	6.2 (1.5)	5.5 (1.5)
Discharge	4.0 (1.1)	4.9 (1.7)	5.4 (1.5)	5.7 (1.6)	5.0 (1.4)	5.1 (1.6)
6 months	4.1 (0.9)	4.5 (1.0)	4.8 (1.4)	5.2 (1.0)	5.4 (1.6)	4.8 (1.2)

13. Secondary Outcome

Title	Subject's Average Cardiac Index
Description	A measure of cardiac output per square meter of body surface area
Time Frame	Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
Discharge	2.3 (0.6)	2.7 (0.8)	2.8 (0.8)	2.8 (0.8)	2.4 (0.7)	2.7 (0.8)
6 months	2.4 (0.3)	2.5 (0.6)	2.6 (0.9)	2.6 (0.5)	2.6 (0.6)	2.6 (0.7)

14. Secondary Outcome

Title	Subject's Amount of Paravalvular Leak Over Time.
Description	Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time Frame	Discharge and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - All Subjects
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
0 None	19 6.9%	59 NaN	45 NaN	45 NaN	14 NaN	182 NaN
+1 Trivial/Trace	1 0.4%	6 NaN	5 NaN	5 NaN	0 NaN	17 NaN
+2 Mild	0 0%	3 NaN	0 NaN	1 NaN	0 NaN	4 NaN
+3 Moderate	0 0%	0 NaN	0 NaN	0 NaN	1 NaN	1 NaN
+4 Severe	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
0 None	18 6.5%	55 NaN	49 NaN	40 NaN	15 NaN	177 NaN
+1 Trivial/Trace	1 0.4%	6 NaN	4 NaN	4 NaN	0 NaN	15 NaN
+2 Mild	1 0.4%	1 NaN	0 NaN	1 NaN	0 NaN	3 NaN
+3 Moderate	0 0%	0 NaN	0 NaN	0 NaN	1 NaN	1 NaN
+4 Severe	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN

15. Secondary Outcome

Title	Subject's Amount of Aortic Valvular Regurgitation Over Time.
Description	Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
Time Frame	Discharge and 6 Months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort - 19mm	Per Protocol Cohort - 21mm	Per Protocol Cohort - 23mm	Per Protocol Cohort - 25mm	Per Protocol Cohort - 27mm	Per Protocol Cohort - Total
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	29	89	75	63	20	276
0 None	15 5.4%	61 NaN	48 NaN	40 NaN	14 NaN	178 NaN
+1 Trivial/Trace	5 1.8%	7 NaN	3 NaN	11 NaN	1 NaN	27 NaN
+2 Mild	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
+3 Moderate	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
+4 Severe	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
0 None	14 5.1%	54 NaN	46 NaN	40 NaN	13 NaN	167 NaN
+1 Trivial/Trace	6 2.2%	8 NaN	8 NaN	5 NaN	3 NaN	30 NaN
+2 Mild	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
+3 Moderate	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
+4 Severe	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN

16. Other Pre-specified Outcome

Title	Subject's Average SF-36 Physical Health Summary
Description	The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
Baseline	42.6 (8.1)
6 months	47.6 (8.1)

17. Other Pre-specified Outcome

Title	Subject's Average SF-36 Mental Health Summary
Description	The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
Baseline	45.5 (10.4)
6 months	50.1 (10.1)

18. Other Pre-specified Outcome

Title	Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
Description	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
Time Frame	6 months compared to baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	239
Class I	9 3.3%
Class II	0 0%
Class III	0 0%
Class IV	0 0%
Class I	85 30.8%
Class II	25 9.1%
Class III	1 0.4%
Class IV	0 0%
Class I	71 25.7%
Class II	38 13.8%
Class III	6 2.2%
Class IV	0 0%
Class I	4 1.4%
Class II	0 0%
Class III	0 0%
Class IV	0 0%
Class I	169 61.2%
Class II	63 22.8%
Class III	7 2.5%
Class IV	0 0%

19. Other Pre-specified Outcome

Title	Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
Description	The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
Baseline	0.73 (0.21)
6 months	0.82 (0.22)

20. Other Pre-specified Outcome

Title	Subject's Average Fitness for Hospital Discharge
Description	Considered as the day at which the patient was fit for hospital discharge.
Time Frame	Day of surgical procedure through discharge from the hospital; an average of 7 days

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	275
Mean (Standard Deviation) [days]	6.8 (6.1)

21. Other Pre-specified Outcome

Title	Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Description	Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Time Frame	Events occurring within 30 days of procedure

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
All Cause Mortality	1.1
Trial Valve Related Mortality	0.0
Thromboembolism	3.6
Stroke	2.9
TIA	0.0
Non-cerebral Embolism	0.7
Valve Thrombosis	0.0
Major Bleeding	0.4
Minor Paravalvular Leak (OPC)	0.4
Major Paravalvular Leak (OPC)	0.4
Hemolysis	0.0
NSVD Other than PVL	0.0
Endocarditis	0.0
Structural Valve Deterioration	0.0
Reoperation	0.0
Explant	0.0
Renal Failure	2.2
Respiratory Failure/Dysfunction	1.1
Deep Sternal Wound Infection	0.7
Permanent Pacemaker Implant	6.7

22. Other Pre-specified Outcome

Title	Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Description	Number of late adverse events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Time Frame	Events occuring >= 31 days and up through 6 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.

Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort consists of all enrolled patients that left the operating room with the registry valve in place and had an AVR MIS surgery procedure.
Measure Participants	276
All Cause Mortality	6.1
Trial Valve Related Mortality	3.5
Thromboembolism	1.7
Stroke	1.7
TIA	0.0
Non-cerebral Embolism	0.0
Valve Thrombosis	0.0
Major Bleeding	2.6
Minor Paravalvular Leak (OPC)	0.0
Major Paravalvular Leak (OPC)	0.9
Hemolysis	0.0
NSVD Other than PVL	0.9
Endocarditis	0.0
Structural Valve Deterioration	0.9
Reoperation	1.7
Explant	1.7
Renal Failure	0.0
Respiratory Failure/Dysfunction	0.9
Deep Sternal Wound Infection	1.7
Permanent Pacemaker Implant	1.8

Adverse Events

Time Frame	Events occurring from baseline through 6 months post implant
Adverse Event Reporting Description	This outcome is reported for subjects who received an EDWARDS INTUITY Elite Valve System where data is available.
Arm/Group Title	Per Protocol Cohort
Arm/Group Description	The per protocol cohort will consist of all enrolled patients that leave the operating room with the registry valve in place and had an AVR MIS surgery procedure.
All Cause Mortality
	Per Protocol Cohort
	Affected / at Risk (%)	# Events
Total	10/280 (3.6%)
Serious Adverse Events
	Per Protocol Cohort
	Affected / at Risk (%)	# Events
Total	108/280 (38.6%)
Blood and lymphatic system disorders
Anemia - Bleeding related - Minor	1/280 (0.4%)	1
Bleeding - Cardiovascular - Major	7/280 (2.5%)	7
Bleeding - Gastrointestinal Lower - Minor	1/280 (0.4%)	1
Bleeding - Gastrointestinal Upper - Major	1/280 (0.4%)	1
Bleeding - Gastrointestinal Upper - Minor	1/280 (0.4%)	1
Bleeding - Neurological - Major	1/280 (0.4%)	1
Splenic complication	1/280 (0.4%)	1
Cardiac disorders
Arrhythmia - AV Block - 1st degree	2/280 (0.7%)	2
Arrhythmia - AV Block - 2nd degree	2/280 (0.7%)	2
Arrhythmia - AV Block - 3rd degree	11/280 (3.9%)	11
Arrhythmia - Atrial Flutter	4/280 (1.4%)	4
Arrhythmia - Bradycardia	1/280 (0.4%)	1
Arrhythmia - Bundle Branch Block - Left	1/280 (0.4%)	1
Arrhythmia - Other	1/280 (0.4%)	1
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	16/280 (5.7%)	17
Arrhythmia - Permanent Atrial Fibrillation	1/280 (0.4%)	1
Arrhythmia - Persistent Atrial Fibrillation	7/280 (2.5%)	8
Arrhythmia - Supraventricular Tachycardia (SVT)	2/280 (0.7%)	2
Arrhythmia - Tachy-Bradycardia	1/280 (0.4%)	1
Arrhythmia - Ventricular Fibrillation	1/280 (0.4%)	1
Cardiac Arrest	3/280 (1.1%)	3
Chordae tendineae damage	1/280 (0.4%)	1
Heart Failure - Acute	7/280 (2.5%)	8
Heart Failure - Chronic (CHF)	1/280 (0.4%)	1
Myocardial Infarction	1/280 (0.4%)	1
NSVD - LVOT damage	1/280 (0.4%)	1
NSVD - Paravalvular Leak - +2	2/280 (0.7%)	2
Perforation - Atrial	1/280 (0.4%)	1
Pericardial Effusion - Major	6/280 (2.1%)	6
Pericardial Effusion - Minor	1/280 (0.4%)	1
Pericardial Tamponade	10/280 (3.6%)	10
Pleural Effusion - Bilateral	4/280 (1.4%)	4
Pleural Effusion - Left	3/280 (1.1%)	4
Pleural Effusion - Right	2/280 (0.7%)	2
Thromboembolic Event - Other - Central - Hemiparesis	2/280 (0.7%)	2
Thromboembolic Event - Stroke	8/280 (2.9%)	8
Ear and labyrinth disorders
Hearing disorder	1/280 (0.4%)	1
Gastrointestinal disorders
Biliary (Gallbladder)	1/280 (0.4%)	1
Gastrointestinal - Infection	1/280 (0.4%)	1
Gastrointestinal - Other	3/280 (1.1%)	3
Pancreatic complication	1/280 (0.4%)	1
General disorders
Cancer - Newly diagnosed	1/280 (0.4%)	1
Cancer - Progression of underlying disease	1/280 (0.4%)	1
Fever - Unknown Origin	2/280 (0.7%)	2
Multi-System organ failure	1/280 (0.4%)	1
Nonspecific, Unknown, or Other Body System - Other complication	3/280 (1.1%)	3
Sudden, Unexplained Death	1/280 (0.4%)	1
Infections and infestations
Deep Sternal Wound / Thoracic Infection	4/280 (1.4%)	4
Infection / Inflammation - Other	2/280 (0.7%)	2
Superficial Wound Infection - Sternal	3/280 (1.1%)	3
Musculoskeletal and connective tissue disorders
Bone Fracture / Break	1/280 (0.4%)	1
Muscular Skeletal / Dermatologic - Other	1/280 (0.4%)	1
Psychiatric disorders
Psychiatric - Other	1/280 (0.4%)	1
Psychiatric Disorder	1/280 (0.4%)	1
Transient Psychotic Syndrome	3/280 (1.1%)	3
Renal and urinary disorders
Renal Dysfunction	1/280 (0.4%)	1
Renal Failure - Acute	4/280 (1.4%)	4
Renal - Other	1/280 (0.4%)	1
Urinary Tract Infection (UTI)	1/280 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Pneumothorax	2/280 (0.7%)	2
Pulmonary Embolism - Right	1/280 (0.4%)	1
Respiratory Failure - COPD	2/280 (0.7%)	2
Respiratory Failure - Other	1/280 (0.4%)	1
Respiratory Failure - Pneumonia	1/280 (0.4%)	1
Respiratory Infection - Lower (Bronchitis)	2/280 (0.7%)	2
Respiratory Infection - Pneumonia	4/280 (1.4%)	4
Respiratory Insufficiency	1/280 (0.4%)	1
Vascular disorders
Vascular - Access Site Complication	1/280 (0.4%)	1
Vascular - Other	1/280 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Per Protocol Cohort
	Affected / at Risk (%)	# Events
Total	155/280 (55.4%)
Blood and lymphatic system disorders
Anemia - Bleeding related - Minor	7/280 (2.5%)	8
Anemia - Non-bleeding related	13/280 (4.6%)	13
Bleeding - Cardiovascular - Major	1/280 (0.4%)	1
Bleeding - Genitourinary - Major	1/280 (0.4%)	1
Bleeding - Genitourinary - Minor	2/280 (0.7%)	2
Bleeding - Musculoskeletal/Dermatological - Minor	2/280 (0.7%)	2
Bleeding - Pulmonary/Respiratory Minor	1/280 (0.4%)	1
Blood/ Lymphatic - Other	2/280 (0.7%)	2
Thrombocytopenia - Heparin Induced (HIT)	1/280 (0.4%)	1
Cardiac disorders
Angina, Stable	1/280 (0.4%)	1
Arrhythmia - AV Block - 1st degree	8/280 (2.9%)	8
Arrhythmia - AV Block - 2nd degree	1/280 (0.4%)	1
Arrhythmia - AV Block - 3rd degree	2/280 (0.7%)	2
Arrhythmia - Atrial Flutter	1/280 (0.4%)	1
Arrhythmia - Bradycardia	4/280 (1.4%)	4
Arrhythmia - Bundle Branch Block - Left	53/280 (18.9%)	53
Arrhythmia - Bundle Branch Block - Right	3/280 (1.1%)	3
Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	57/280 (20.4%)	59
Arrhythmia - Paroxysmal Atrial Tachycardia (PAT)	1/280 (0.4%)	1
Arrhythmia - Persistent Atrial Fibrillation	13/280 (4.6%)	13
Arrhythmia - Tachy-Bradycardia	1/280 (0.4%)	1
Arrhythmia - Tachycardia - Non-Ventricular	4/280 (1.4%)	5
Arrhythmia - Tachycardia - Ventricular	3/280 (1.1%)	3
Arrhythmia - Ventricular Fibrillation	1/280 (0.4%)	1
Cardiogenic Shock	1/280 (0.4%)	1
Cardiovascular - Other	1/280 (0.4%)	1
Hypertension - Pulmonary	1/280 (0.4%)	1
Hypertension - Systemic	5/280 (1.8%)	5
Hypotension	1/280 (0.4%)	1
NSVD - Paravalvular Leak - +1	2/280 (0.7%)	2
NSVD - Paravalvular Leak - +2	1/280 (0.4%)	1
Pericardial Effusion - Minor	1/280 (0.4%)	1
Pleural Effusion - Bilateral	3/280 (1.1%)	3
Pleural Effusion - Left	4/280 (1.4%)	4
Pleural Effusion - Right	9/280 (3.2%)	9
Regurgitation - Aortic-Central/Transvalvular-+1	1/280 (0.4%)	1
Endocrine disorders
Endocrine complications	1/280 (0.4%)	1
Gastrointestinal disorders
Gastrointestinal - Other	2/280 (0.7%)	2
General disorders
Fever - Unknown Origin	2/280 (0.7%)	2
Nonspecific, Unknown, or Other Body System - Other complication	5/280 (1.8%)	5
Hepatobiliary disorders
Hepatic complication - Other	1/280 (0.4%)	1
Infections and infestations
Gastrointestinal - Infection	1/280 (0.4%)	1
Infection / Inflammation - Other	1/280 (0.4%)	1
Respiratory Infection - Lower (Bronchitis)	1/280 (0.4%)	1
Respiratory Infection - Pneumonia	3/280 (1.1%)	3
Superficial Wound Infection - Sternal	3/280 (1.1%)	3
Wound Infection - Other	2/280 (0.7%)	2
Metabolism and nutrition disorders
Metabolic complications	2/280 (0.7%)	2
Musculoskeletal and connective tissue disorders
Bone Fracture / Break	1/280 (0.4%)	1
Muscular Skeletal / Dermatologic - Other	3/280 (1.1%)	3
Psychiatric disorders
Psychiatric - Other	4/280 (1.4%)	4
Psychiatric Disorder	2/280 (0.7%)	2
Transient Psychotic Syndrome	11/280 (3.9%)	11
Renal and urinary disorders
Renal Dysfunction	7/280 (2.5%)	7
Renal Failure - Acute	6/280 (2.1%)	6
Urinary Tract Infection (UTI)	6/280 (2.1%)	6
Respiratory, thoracic and mediastinal disorders
Pneumothorax	3/280 (1.1%)	3
Pulmonary/Respiratory - Other	1/280 (0.4%)	1
Respiratory Insufficiency	1/280 (0.4%)	1
Vascular disorders
Vascular - Access Site Complication	1/280 (0.4%)	1
Vascular - Other	1/280 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.