An interventional study of Perceval S Aortic Heart Valve in Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency and Regurgitation, Aortic Valve, sponsored by Sorin Group USA, Inc.. Terminated at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-16.
Sponsored by Sorin Group USA, Inc. · Not applicable, Interventional, and Treatment
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 355 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Sorin Group USA, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Treatment with the Perceval S Aortic Heart Valve
Device: Perceval S Aortic Heart Valve
Perceval S Sutureless Aortic Heart Valve
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
Supplementary Analyses
Rates of cross-clamp time, cardiopulmonary bypass time, length of stay in ICU, length of hospital, and quality of life
Time frame: Discharge
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Sorin Group USA, Inc.