Trial Outcomes & Findings for ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study (NCT NCT01116037)

Results Overview

Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Six Years

Results posted on

2017-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	ATS 3f Aortic Bioprosthesis ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve
Overall Study STARTED	26
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATS 3f Aortic Bioprosthesis n=26 Participants ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve
Age, Continuous	60.8 years STANDARD_DEVIATION 7.4 • n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Region of Enrollment Canada	17 Participants n=99 Participants
Region of Enrollment United States	9 Participants n=99 Participants

PRIMARY outcome

Timeframe: Six Years

Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.

Outcome measures

Outcome measures
Measure	ATS 3f Aortic Bioprosthesis n=1 Participants ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve
Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000	1 Participants

SECONDARY outcome

Timeframe: Six Years

Safety Analysis will be based on the the number of participants with cardiovascular complications.

Outcome measures

Outcome measures
Measure	ATS 3f Aortic Bioprosthesis n=26 Participants ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve
Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.	11 participants

Adverse Events

ATS 3f Aortic Bioprosthesis

Serious events: 8 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ATS 3f Aortic Bioprosthesis n=26 participants at risk ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve
Cardiac disorders Cardiovascular Complications	30.8% 8/26 • Number of events 10 • 6 years

Other adverse events

Other adverse events
Measure	ATS 3f Aortic Bioprosthesis n=26 participants at risk ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis) ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve
Cardiac disorders Valve Dysfunction	11.5% 3/26 • Number of events 3 • 6 years
Vascular disorders Vascular Complication	7.7% 2/26 • Number of events 2 • 6 years

Additional Information

Ryan Palmer

Medtronic

Phone: +17635149732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place