Perceval S Aortic Heart Valve Study- North America

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Aortic Valve Incompetence
Aortic Valve Insufficiency
Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Constriction, Pathologic
Heart Defects, Congenital
Heart Valve Diseases
Regurgitation, Aortic Valve

Clinical Trial Details

NCT number	NCT01810679
Study type	Interventional
Source	Sorin Group USA, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	April 2013
Completion date	April 2018

View Details

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