Clinical trial NCT01116024: ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
Official title: ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Diseased Heart Valve, Replacement, Aortic
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 173
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thromboembolism/Thrombosis
timeFrame: Five Years
measure: Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
timeFrame: Five Years
measure: Paravalvular Leaks (All and Major)
timeFrame: Five Years
measure: Endocarditis
timeFrame: Five Years
measure: Hemolysis
timeFrame: Five Years
measure: Structural Valve Deterioration
timeFrame: Five Years
measure: Non-Structural Dysfunction
timeFrame: Five Years
measure: Re-operation, Explant, Repair
timeFrame: Five Years
measure: Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
timeFrame: Five Years
measure: Hemodynamic
timeFrame: Five Years
measure: Hemodynamics - Effective Orifice Area
timeFrame: Five Years
measure: Hemodynamics - Effective Orifice Area Index
timeFrame: Five Years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Kiel
country: Germany
facility: University Medical Center Kiel
city: Lubeck
country: Germany
facility: UKSH, Campus Lubeck
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Krakow
country: Poland
facility: Jagiellonian University
city: Basel
country: Switzerland
facility: Cardiac Surgery University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Medtronic
name: Eric Vang
role: STUDY_DIRECTOR
References: