Trial Outcomes & Findings for Medtronic CoreValve REDO Study (NCT NCT01051310)

Results Overview

Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 1. MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement. 2. MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

30 days post-procedure

Results posted on

2019-01-31

Participant Flow

Three sites in Germany enrolled 18 patients between June 2008 and January 2010.

All 18 subjects signed and informed consent and were admitted to the catheterization laboratory for an attempted implantation. All 18 subjects were subsequently implanted with the CoreValve device.

Participant milestones

Participant milestones
Measure	Overall Study All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
Overall Study STARTED	18
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medtronic CoreValve REDO Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=18 Participants All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-procedure

Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 1. MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement. 2. MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure.

Outcome measures

Outcome measures
Measure	Overall Study n=18 Participants All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
Percentage of MAE Free Subjects	10 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

The number of subjects in whom technical success was achieved where technical success was defined based on the device functionality as judged by the investigator adressing the ability of the system (1) to access the failing bioprosthetic valve via a peripheral vessel with the delivery catheter and (2) to deploy the valve accurately across the failing bioprosthetic valve and (3) to remove intact delivery system.

Outcome measures

Outcome measures
Measure	Overall Study n=18 Participants All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
Technical Success.	17 Participants

Adverse Events

Overall Study

Serious events: 15 serious events

Other events: 14 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Overall Study n=18 participants at risk All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
Cardiac disorders Myocardial infarction	5.6% 1/18 • Number of events 1 • Adverse events were collected from implantation till 12 months follow up
Cardiac disorders Documented Mobitz type II AVB II, AVB III	27.8% 5/18 • Number of events 25 • Adverse events were collected from implantation till 12 months follow up
General disorders	66.7% 12/18 • Number of events 19 • Adverse events were collected from implantation till 12 months follow up
Injury, poisoning and procedural complications bleeding event	11.1% 2/18 • Number of events 2 • Adverse events were collected from implantation till 12 months follow up
Nervous system disorders Neurological events (CVA, RIND, TIA)	11.1% 2/18 • Number of events 2 • Adverse events were collected from implantation till 12 months follow up
Product Issues non structural valve dysfunction	5.6% 1/18 • Number of events 1 • Adverse events were collected from implantation till 12 months follow up
Surgical and medical procedures Surgical aortic valve replacement	11.1% 2/18 • Number of events 2 • Adverse events were collected from implantation till 12 months follow up

Other adverse events

Other adverse events
Measure	Overall Study n=18 participants at risk All enrolled subjects who received the Medtronic CoreValve aortic valve prosthesis
General disorders	72.2% 13/18 • Number of events 44 • Adverse events were collected from implantation till 12 months follow up
Injury, poisoning and procedural complications bleeding event	5.6% 1/18 • Number of events 1 • Adverse events were collected from implantation till 12 months follow up

Additional Information

M. Hollander

Medtronic

Phone: +31620534428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place