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

Covidien

Status

Completed

Conditions

Heart Valve Diseases

Treatments

Device: ATS 3f Enable Aortic Bioprosthesis Model 6000

Study type

Interventional

Funder types

Industry

Identifiers

NCT01116024

S2005 Rev. 17-MAY-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment

173 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue).
The patient is geographically stable and willing to return to the implant site for follow-up visits.
The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study.
If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.

Exclusion criteria

The patient requires replacement of two or more valves.
The patient is < 20 years of age.
The patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months.
The patient is an intravenous drug and/or alcohol abuser.
The patient presents with active endocarditis or other systemic infection.
The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position.
The patient is participating in concomitant research studies of investigational products.
The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.
The patient has chronic renal failure.