NCT01116024

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	ATS 3f Enable Aortic Bioprosthesis Model 6000	Replacement Aortic Heart Valve

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-12-01
• Completion: 2012-08-01
• First posted: 2010-05-04
• Last updated: 2018-06-26
• Results posted: 2016-12-05

Locations

10 sites across 5 countries: Austria, Germany, Poland, Switzerland, United Kingdom