Clinical Investigation of the Perceval S Sutureless Heart Valve
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Sorin Group USA, Inc.
- Enrollment
- 355
- Locations
- 39
- Primary Endpoint
- Primary Efficacy Endpoint
Study Overview
Brief Summary
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Detailed Description
This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Efficacy Endpoint
Time Frame: One-year
To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls
Primary Safety Endpoint
Time Frame: One-year
To demonstrate that the complication and survival rates for the PERCEVAL S valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported for other stented bioprostheses in the literature
Secondary Outcomes
- Secondary Efficacy Outcomes(One-year)