ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
Summary
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (
Description
A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.
Study Design
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Heart Valve Diseases
Intervention
ATS 3f Aortic Bioprosthesis
Location
UCLA Medical Center
Los Angeles
California
United States
90095
Status
Enrolling by invitation
Source
ATS Medical, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01116037
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-24T14:05:53-0400
Clinical Trials
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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and e...
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PubMed Articles
Novel Treatment Of A Degenerated Bioroot With The Use Of The Sutureless Valve Technique.
We describe three patients with severe aortic regurgitation after aortic root replacement using the Medtronic Freestyle® bioprosthesis. In two cases, the indication was endocarditis. The third case s...
Aortic Valve Replacement With Perceval Bioprosthesis: Single-Center Experience With 617 Implants.
This study describes the clinical and echocardiographic outcomes in a large single-center cohort of patients who underwent aortic valve replacement (AVR) with a sutureless Perceval (LivaNova, Milan, I...
Structural valve deterioration in the Mitroflow biological heart valve prosthesis.
Concern has been raised regarding the long-term durability of the Mitroflow biological heart valve prosthesis. Our aim was to assess the incidence of structural valve degeneration (SVD) for the Mitrof...
Sutureless aortic bioprostheses (SAB) provide shorter aortic cross-clamp time and cardiopulmonary bypass duration compared to conventional aortic valve replacement. Similarly to other bioprostheses, r...
Heart valve replacement with a bioprosthesis is one of the most frequently performed procedures in cardiac surgery and represents a highly effective therapy to relieve diseased heart valves. Neverthel...
Medical and Biotech [MESH] Definitions
Transcatheter Aortic Valve Replacement
Surgical treatment for severe AORTIC VALVE STENOSIS. Transcatheter aortic valve replacement (TAVR) is used as an alternative option in patients who are deemed at high risk or inoperable for traditional open-heart surgery.
Heart Valve Prosthesis
A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material.
Aortic Valve Insufficiency
Pathological condition characterized by the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to regurgitation. It is caused by diseases of the AORTIC VALVE or its surrounding tissue (aortic root).
Aortic Valve Prolapse
The downward displacement of the cuspal or pointed end of the trileaflet AORTIC VALVE causing misalignment of the cusps. Severe valve distortion can cause leakage and allow the backflow of blood from the ASCENDING AORTA back into the LEFT VENTRICLE, leading to aortic regurgitation.
Hypoplastic Left Heart Syndrome
A condition caused by underdevelopment of the whole left half of the heart. It is characterized by hypoplasia of the left cardiac chambers (HEART ATRIUM; HEART VENTRICLE), the AORTA, the AORTIC VALVE, and the MITRAL VALVE. Severe symptoms appear in early infancy when DUCTUS ARTERIOSUS closes.
