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ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000 — Enable  

Heart Valve Diseases Clinical Trial

Official title:
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000

Clinical Trial Summary

This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.

Clinical Trial Description

The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01116024
Study type Interventional
Source Medtronic Cardiovascular
Contact
Status Completed
Phase N/A
Start date May 2006
Completion date August 2012
View Details
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