Status:
WITHDRAWN
Post Market ATS 3f® Aortic Bioprosthesis, Model 1000, Size 19mm
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the ATS 3f® Aortic Bioprosthesis, Model 1000 (Equine Pericardial Bioprothesis) size 19mm in a patient population undergoing isolated...
Detailed Description
A multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm Model 1000 heart valve. Each enrolled patient will be followed...
Eligibility Criteria
Inclusion
- The patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ATS 3f® Aortic Bioprosthesis Model 1000 (size 19mm) between the dates of 1-Jan-2009 and 31-Dec-2009. The three remaining heart valves must be of native tissue.
- The patient is geographically stable and willing to return to the implant center for any required follow-up visits.
- The patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Exclusion
- The patient is twenty (20) or less than twenty years of age.
- The patient is an intravenous drug and/or alcohol abuser.
- The patient presented for implant with active endocarditis.
- The patient presented for implant with congenital bicuspid aortic anatomy.
- The patient had a previously implanted prosthetic valve that was not replaced by the study valve.
- The patient required mitral, tricuspid or pulmonic valve replacement.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01156272
Start Date
June 1 2010
End Date
June 1 2011
Last Update
August 6 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1