aortic valve replacement cardiac valve prosthesis
Conditions
Interventions
The ATS 3f Enable* Aortic Bioprosthesis was developed for aortic valve
replacement.
The ENABLE bioprosthesis is supplied sterile. A polyacetal homopolymer folding
sleeve is attached to the bioprost
Sponsors
ATS Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Preoperative Inclusion Criteria 1. This patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue). 2. This patient is geographically stable and willing to return to the implant site for follow-up visits. 3. This patient has been adequately informed of risks and requirements and consents to his/her participation in the clinical study. 4. If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.
Exclusion criteria
Exclusion criteria: Preoperative Exclusion Criteria 1. This patient requires replacement of two or more valves. 2. This patient is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoints will be determined by the New York Heart Association (NYHA) functional classification by comparing baseline (preoperatively) to each postoperative assessment. Additionally, NYHA functional classification data will be compared to data for other similar valves (stented bioprosthetic valves) published in articles in the prosthetic heart valve literature. Hemodynamic performance of the implanted valve will be evaluated at each postoperative assessment. The primary safety endpoints for the study are valve migration, valvular thrombosis, valve related thromboembolism, hemorrhage (all and major), perivalvular leak (all and major), endocarditis, hemolysis, structural valve deterioration, nonstructural dysfunction, reoperation, explant, and death (all and valve related). | — |
Secondary
| Measure | Time frame |
|---|---|
| Long term safety endpoints will be compared to twice the Objective Performance Criteria (OPC) events as is standard for prosthetic heart valve studies. | — |
Countries
Netherlands
Outcome results
None listed