CoreValve Advance International Post Market Study

• Sponsor: Medtronic Bakken Research Center (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01074658
• Collaborator: (none)
• Enrollment: 1,015
• Locations: 44
• Duration (Months): 86
• Patients Per Site: 23.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Condition or Disease	Intervention/Treatment	Phase
Severe Aortic Stenosis	Device: Medtronic CoreValve System

Detailed Description

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Study Design

• Study Type: Observational
• Actual Enrollment: 1015 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
severe aortic valve stenosis elderly patients with severe aortic valve stenosis requiring treatment	Device: Medtronic CoreValve System; Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Outcome Measures

Primary Outcome Measures

1. Major Adverse Cardiac & Cerebrovascular Events (MACCE) [30 days]

   MACCE is defined as a composite of: All cause mortality Myocardial Infarction (Q-wave and non-Q-wave) Emergent cardiac surgery or percutaneous re-intervention Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.

Secondary Outcome Measures

1. Percentage of Participants With Device Success [up to 24 hours]

   Device Success is defined as a composite of: Successful device delivery; Stable device placement; Intact retrieval of delivery catheter; Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation

2. Percentage of Participants With Procedural Success [up to 30 days]

   Procedural success, defined as device success with absence of in-hospital MACCE

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients with severe aortic valve stenosis requiring treatment

• Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context

• Patient is above the minimum age as required by local regulations to be participating in a clinical study

• The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")

Exclusion Criteria:

• Currently participating in another trial

• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ZNA Antwerpen Middelheim	Antwerpen		Belgium	2020
2	Antwerpen UZA	Antwerp		Belgium	2650
3	CHU Sart Tillman	Liege		Belgium	4000
4	Angiografia de Occidente	Cali		Colombia
5	Rigshospitalet	Copenhagen		Denmark	DK2100
6	Hopital Henri Mondor	Creteil		France	94010
7	Hopital Cardiologique	Lille		France	59037
8	Hopital Louis Pradel	Lyon		France	69677
9	Institut Hospitalier Jacques Cartier	Massy		France	91300
10	Groupe Hospitalier Pitie-Salpetriere	Paris Cedex		France	75013
11	Clinique Pasteur	Toulouse Cedex		France	31076
12	Universitätsklinikum Aachen	Aachen		Germany	52057
13	Bernau Herzzentrum Brandenburg	Bernau b. Berlin		Germany	16321
14	CardioVascular Center Frankfurt	Frankfurt		Germany	60389
15	Asklepios Klinik St. Georg Hamburg	Hamburg		Germany	20099
16	Universitat Leipzig Herzzentrum	Leipzig		Germany	04289
17	Deutsches Herzzentrum Munchen	Munchen		Germany	80636
18	Helios Herzzentrum Siegburg Gmbh	Siegburg		Germany	53721
19	Onassis cardiac surgery center	Athens		Greece	17674
20	Hadassah Medical Center	Jerusalem		Israel	91120
21	Sheba Medical Center	Tel Aviv		Israel	52621
22	Ichilov Medical Center	Tel Aviv		Israel	64239
23	Azienda Ospedaliere Spedali Civili di Brescia	Brescia		Italy	25123
24	Policlinico Vittorio Emanuele, P.O. Ferrarotto	Catania		Italy	95024
25	Azienda Ospedaliero-Universitaria Careggi	Firenze		Italy	50134
26	Ospedale Civile	Legnano		Italy
27	Ospedale Niguarda Ca'Granda	Milano		Italy	20025
28	Fondazione Centro San Raffaele	Milano		Italy
29	Istituto Clinico S.Ambrogio	Milano		Italy
30	Istituto Clinico Humanitas	Rozzano		Italy	20089
31	AMC Ziekenhuis	Amsterdam		Netherlands	1100 DD
32	Amphia Breda	Breda		Netherlands	4818 CK
33	Catharina Hospital	Eindhoven		Netherlands	5623 EJ
34	St. Antonius Ziekenhuis	Nieuwegein		Netherlands	3435 CM
35	Hospital de Santa Cruz	Lisbon		Portugal	2799-523
36	Centro Hospitalar de Vila Nova de Gaia	Porto		Portugal	4400
37	Universtiy Hospital Isel Bern	Bern		Switzerland	3010
38	Universitätsspital Zürich	Zurich		Switzerland	8091
39	Brighton and Sussex Hospital	Brighton		United Kingdom	BN25BE
40	Leeds General Infirmary	Leeds		United Kingdom	LS13EX
41	Leicester Hospital	Leicester		United Kingdom	Le3 9 QP
42	St. George's Hospital	London		United Kingdom	SW170QT
43	The Heart Hospital	London		United Kingdom	W1G8PH
44	Newcross Hospital Wolverhampton	Wolverhampton		United Kingdom	WV10 OEN

Sponsors and Collaborators

• Medtronic Bakken Research Center

Investigators

• Principal Investigator: Axel Linke, Prof Dr med, Universitat Leipzig Herzzentrum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Bakken Research Center
• ClinicalTrials.gov Identifier: NCT01074658
• Other Study ID Numbers: Advance
• First Posted: Feb 24, 2010
• Last Update Posted: Dec 2, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Medtronic Bakken Research Center: Advance; Medtronic CoreValve System; International; Interventional; Post Market Study
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

Participant Flow

Recruitment Details	Start Recruitment March 2010 > End Recruitment July 2011

Arm/Group Title	Medtronic CoreValve System
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
Period Title: Overall Study
STARTED	1015
Attempted Implant	996
COMPLETED	996
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Medtronic CoreValve System
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
Overall Participants	1015
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81.1 (6.4)
Sex: Female, Male (Count of Participants)
Female	514 50.6%
Male	501 49.4%

Outcome Measures

1. Primary Outcome

Title	Major Adverse Cardiac & Cerebrovascular Events (MACCE)
Description	MACCE is defined as a composite of: All cause mortality Myocardial Infarction (Q-wave and non-Q-wave) Emergent cardiac surgery or percutaneous re-intervention Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All attempted population.

Arm/Group Title	Medtronic CoreValve System
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Measure Participants	996
Number [Freedom from MACCE (%) @30days]	92

2. Secondary Outcome

Title	Percentage of Participants With Device Success
Description	Device Success is defined as a composite of: Successful device delivery; Stable device placement; Intact retrieval of delivery catheter; Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation
Time Frame	up to 24 hours

Outcome Measure Data

Analysis Population Description

All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable.

Arm/Group Title	Medtronic CoreValve System
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Measure Participants	578
Number [percentage of participants]	79.4 7.8%

3. Secondary Outcome

Title	Percentage of Participants With Procedural Success
Description	Procedural success, defined as device success with absence of in-hospital MACCE
Time Frame	up to 30 days

Outcome Measure Data

Analysis Population Description

All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable.

Arm/Group Title	Medtronic CoreValve System
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Measure Participants	613
Number [percentage of participants]	71.1 7%

Adverse Events

Time Frame	30 days post procedure
Arm/Group Title	Medtronic CoreValve System
Arm/Group Description	Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
All Cause Mortality
	Medtronic CoreValve System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Medtronic CoreValve System
	Affected / at Risk (%)	# Events
Total	541/996 (54.3%)
Cardiac disorders
Cardiac tamponade	3/996 (0.3%)	3
Bradycardia	4/996 (0.4%)	4
Ventricular fibrillation	6/996 (0.6%)	6
Arrhythmia	18/996 (1.8%)	18
Myocardial Infarction	110/996 (11%)	110
Structural Valve Deterioration	1/996 (0.1%)	1
Nonstructural Valve Dysfunction	7/996 (0.7%)	7
General disorders
Death	45/996 (4.5%)	45
Other Serious Adverse Event	213/996 (21.4%)	286
Injury, poisoning and procedural complications
Vessel dissection	4/996 (0.4%)	4
Access site complication	6/996 (0.6%)	6
Access vessel dissection	21/996 (2.1%)	21
Access vessel perforation	15/996 (1.5%)	15
Acute vessel occlusion	7/996 (0.7%)	7
Hemorrhage requiring transfusion	9/996 (0.9%)	9
Reposition with snare	2/996 (0.2%)	2
Valve in valve	15/996 (1.5%)	15
Valve retrieval	4/996 (0.4%)	4
Valve dislocation into LVOT	1/996 (0.1%)	1
Valve dislocation into annular aorta	6/996 (0.6%)	6
Ventricular rupture	3/996 (0.3%)	3
Other Procedural Complication	23/996 (2.3%)	25
Nervous system disorders
Stroke/TIA	30/996 (3%)	30
Renal and urinary disorders
Renal Failure	35/996 (3.5%)	36
Surgical and medical procedures
Resuscitation	9/996 (0.9%)	9
Failure of closure device requiring surgery	11/996 (1.1%)	11
Permanent Pacemaker Implantation	209/996 (21%)	209
Vascular disorders
Hemodynamic instability requiring Heart/Lung machine	2/996 (0.2%)	2
Bleeding Event	87/996 (8.7%)	91
Other (Not Including Serious) Adverse Events
	Medtronic CoreValve System
	Affected / at Risk (%)	# Events
Total	541/996 (54.3%)
General disorders
AE related to Device	84/996 (8.4%)	101
AE related to Index procedure	535/996 (53.7%)	883

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

PI will provide results to sponsor for review and approval at least 60 days prior to submittal for publication or presentation. Review will be limited to determination whether Confidential Information is disclosed and not to censor or interfere with presentation or conclusions beyond the extent necessary to protect Confidential Information, to allow the sponsor to protect its rights in patentable or copyrightable material, and to check for technical correctness of sponsor information.