Trial Outcomes & Findings for CoreValve Advance International Post Market Study (NCT NCT01074658)

Last Updated: 2017-12-02

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1015 participants

Primary outcome timeframe

30 days

Results posted on

2017-12-02

Participant Flow

Start Recruitment March 2010 \> End Recruitment July 2011

Participant milestones

Participant milestones
Measure	Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
Overall Study STARTED	1015
Overall Study Attempted Implant	996
Overall Study COMPLETED	996
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
Overall Study No implant attempted	19

Baseline Characteristics

CoreValve Advance International Post Market Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medtronic CoreValve System n=1015 Participants Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
Age, Continuous	81.1 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	514 Participants n=5 Participants
Sex: Female, Male Male	501 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All attempted population.

Outcome measures

Outcome measures
Measure	Medtronic CoreValve System n=996 Participants Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Major Adverse Cardiac & Cerebrovascular Events (MACCE)	92 Freedom from MACCE (%) @30days

SECONDARY outcome

Timeframe: up to 24 hours

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

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

Outcome measures

Outcome measures
Measure	Medtronic CoreValve System n=578 Participants Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Percentage of Participants With Device Success	79.4 percentage of participants

SECONDARY outcome

Timeframe: up to 30 days

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

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

Outcome measures

Outcome measures
Measure	Medtronic CoreValve System n=613 Participants Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Percentage of Participants With Procedural Success	71.1 percentage of participants

Adverse Events

Medtronic CoreValve System

Serious events: 541 serious events

Other events: 541 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medtronic CoreValve System n=996 participants at risk Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
Cardiac disorders Cardiac tamponade	0.30% 3/996 • Number of events 3 • 30 days post procedure
Injury, poisoning and procedural complications Vessel dissection	0.40% 4/996 • Number of events 4 • 30 days post procedure
Injury, poisoning and procedural complications Access site complication	0.60% 6/996 • Number of events 6 • 30 days post procedure
Injury, poisoning and procedural complications Access vessel dissection	2.1% 21/996 • Number of events 21 • 30 days post procedure
Injury, poisoning and procedural complications Access vessel perforation	1.5% 15/996 • Number of events 15 • 30 days post procedure
Injury, poisoning and procedural complications Acute vessel occlusion	0.70% 7/996 • Number of events 7 • 30 days post procedure
Injury, poisoning and procedural complications Hemorrhage requiring transfusion	0.90% 9/996 • Number of events 9 • 30 days post procedure
Cardiac disorders Bradycardia	0.40% 4/996 • Number of events 4 • 30 days post procedure
Injury, poisoning and procedural complications Reposition with snare	0.20% 2/996 • Number of events 2 • 30 days post procedure
Injury, poisoning and procedural complications Valve in valve	1.5% 15/996 • Number of events 15 • 30 days post procedure
Injury, poisoning and procedural complications Valve retrieval	0.40% 4/996 • Number of events 4 • 30 days post procedure
Injury, poisoning and procedural complications Valve dislocation into LVOT	0.10% 1/996 • Number of events 1 • 30 days post procedure
Injury, poisoning and procedural complications Valve dislocation into annular aorta	0.60% 6/996 • Number of events 6 • 30 days post procedure
Injury, poisoning and procedural complications Ventricular rupture	0.30% 3/996 • Number of events 3 • 30 days post procedure
Vascular disorders Hemodynamic instability requiring Heart/Lung machine	0.20% 2/996 • Number of events 2 • 30 days post procedure
Surgical and medical procedures Resuscitation	0.90% 9/996 • Number of events 9 • 30 days post procedure
Cardiac disorders Ventricular fibrillation	0.60% 6/996 • Number of events 6 • 30 days post procedure
Surgical and medical procedures Failure of closure device requiring surgery	1.1% 11/996 • Number of events 11 • 30 days post procedure
Cardiac disorders Arrhythmia	1.8% 18/996 • Number of events 18 • 30 days post procedure
Injury, poisoning and procedural complications Other Procedural Complication	2.3% 23/996 • Number of events 25 • 30 days post procedure
General disorders Death	4.5% 45/996 • Number of events 45 • 30 days post procedure
Nervous system disorders Stroke/TIA	3.0% 30/996 • Number of events 30 • 30 days post procedure
Cardiac disorders Myocardial Infarction	11.0% 110/996 • Number of events 110 • 30 days post procedure
Renal and urinary disorders Renal Failure	3.5% 35/996 • Number of events 36 • 30 days post procedure
Cardiac disorders Structural Valve Deterioration	0.10% 1/996 • Number of events 1 • 30 days post procedure
Cardiac disorders Nonstructural Valve Dysfunction	0.70% 7/996 • Number of events 7 • 30 days post procedure
Vascular disorders Bleeding Event	8.7% 87/996 • Number of events 91 • 30 days post procedure
Surgical and medical procedures Permanent Pacemaker Implantation	21.0% 209/996 • Number of events 209 • 30 days post procedure
General disorders Other Serious Adverse Event	21.4% 213/996 • Number of events 286 • 30 days post procedure

Other adverse events

Other adverse events
Measure	Medtronic CoreValve System n=996 participants at risk Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
General disorders AE related to Device	8.4% 84/996 • Number of events 101 • 30 days post procedure
General disorders AE related to Index procedure	53.7% 535/996 • Number of events 883 • 30 days post procedure

Additional Information

Hanne Gonnissen

Medronic Bakken Research Center

Phone: +3143356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER