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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
355
Perceval S Sutureless Aortic Heart Valve
East Alabama Medical Center
Opelika, Alabama, United States
Primary Safety Endpoint
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
Time frame: One-year
Primary Efficacy Endpoint
To demonstrate that the rate of valve success for the PERCEVAL S valve is comparable to that of appropriate historical controls
Time frame: One-year
Secondary Efficacy Outcomes
To demonstrate that the hemodynamic performance of the PERCEVAL S valve is comparable to that reported in the literature for other stented aortic bioprostheses
Time frame: One-year
Secondary Efficacy Outcomes
To demonstrate clinically significant improvements in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications
Time frame: One-year
Secondary Efficacy Outcomes
To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls
Time frame: One-year
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