Perceval S Aortic Heart Valve Study- North America

Not Applicable

Terminated

• Conditions: Regurgitation, Aortic Valve; Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency; Aortic Valve Incompetence
• Interventions: Device: Perceval S Aortic Heart Valve

• Registration Number: NCT01810679
• Lead Sponsor: Sorin Group USA, Inc.

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 Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Study Start: 2013-04
• Primary Completion: 2016-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perceval S Aortic Heart Valve	Perceval S Aortic Heart Valve	Treatment with the Perceval S Aortic Heart Valve

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint	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	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 Outcome Measures

Name	Time	Method
Secondary Efficacy Outcomes	One-year	To demonstrate that the rate of device technical success for the PERCEVAL S valve is comparable to that of appropriate historical controls

Trial Locations

Locations (21)

Montefiore Medical Center/Albert Einstein College of Medicine; 🇺🇸 New York, New York, United States

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States

Lenox Hill/NS-LIJ; 🇺🇸 New York, New York, United States

New York Presbyterian - Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

East Alabama Medical Center; 🇺🇸 Opelika, Alabama, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Baptist Cardiac and Vascular Institute; 🇺🇸 Miami, Florida, United States

St. Vincent Heart Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Inova Heart and Vascular Institute; 🇺🇸 Falls Church, Virginia, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

St. Vincent's Medical Center; 🇺🇸 Jacksonville, Florida, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States

Oakwood Hospital; 🇺🇸 Dearborn, Michigan, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Cardiothoracic and Vascluar Surgeons; 🇺🇸 Austin, Texas, United States