This trial is active, not recruiting.

Condition heart valve diseases
Treatment ats 3f enable aortic bioprosthesis model 6000
Sponsor Medtronic Cardiovascular
Start date May 2006
End date December 2010
Trial size 173 participants
Trial identifier NCT01116024, S2005 Rev. 17-MAY-2007


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ats 3f enable aortic bioprosthesis model 6000
Replacement Aortic Heart Valve

Primary Outcomes

time frame: One Year
time frame: One Year
Hemorrhage (all and major)
time frame: One Year
Perivalvular Leaks (all and major)
time frame: One Year
time frame: One Year
time frame: One Year
Structural Valve Deterioration
time frame: One Year
Non-Structural Dysfunction
time frame: One Year
Re-operation, Explant, Death (all Deaths and valve related)
time frame: One Year

Secondary Outcomes

Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
time frame: One Year

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.