ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000|
- Migration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Migration is defined as complete or partial displacement (tilting) of the device from its original locus resulting in coronary ostia blockage, perivalvular leak, or incompetence.
- Thromboembolism/Thrombosis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Valve related thromboembolism and valvular thrombosis.
- Hemorrhage (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]All bleeding events regardless of whether or not the event is related to anticoagulation therapy and will be categorized as minor and major events.
- Perivalvular Leaks (all and major) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]All perivalvular leak events will be reported.
- Endocarditis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Study valve endocarditis.
- Hemolysis [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Hematology/Chemistry data will be analyzed to determine if significant subclinical or unreported hemolysis is occuring.
- Structural Valve Deterioration [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Structural valve deterioration data will be collected.
- Non-Structural Dysfunction [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Perivalvular Leak, Hemolysis, Entrapment by pannus, tissue or suture, Inappropriate sizing or positioning, and Distortion.
- Re-operation, Explant, Death (all Deaths and valve related) [ Time Frame: One Year ] [ Designated as safety issue: Yes ]Re-operations, Explant, and Death (all Deaths and valve related)
- Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance [ Time Frame: One Year ] [ Designated as safety issue: No ]NYHA classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Experimental: ATS 3f Enable Aortic Bioprosthesis Model 6000||
Device: ATS 3f Enable Aortic Bioprosthesis Model 6000
Replacement Aortic Heart Valve
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.
|Medical University of Vienna|
|Johann Wolfgang Goethe University|
|University Medical Center Freiburg|
|University Medical Center Kiel|
|UKSH, Campus Lubeck|
|Medical University of Gdansk|
|Cardiac Surgery University Hospital Basel|
|John Radcliffe Hospital|
|Oxford, United Kingdom|
|Study Director:||Eric Vang||Medtronic|