NCT01810679

Perceval S Aortic Heart Valve Study- North America

Clinical Investigation of the Perceval S Sutureless Heart Valve

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Sorin Group USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Stenosis With Insufficiency
• Regurgitation, Aortic Valve
• Aortic Valve Incompetence

Interventions

Type	Name	Description
DEVICE	Perceval S Aortic Heart Valve	Perceval S Sutureless Aortic Heart Valve

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-02-01
• Completion: 2018-04-01
• First posted: 2013-03-13
• Last updated: 2016-11-16

Locations

21 sites across 1 country: United States