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
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PubMed Articles
Aortic valve-in-valve implantation for prosthetic valve dysfunction is a good alternative to reoperative valve replacement. There are some limitations to this approach including the risk of coronary o...
Actuality of pathomorphogenesis investment in calcific aortic valve stenosis.
The increasing of lifetime industrial countries population leads to widespreading diseases of age. Dramatic growth of sclerodegenerative heart valve diseases in last decades is one of the best example...
Late onset valve dislocation of the Edwards Intuity rapid-deployment bioprosthesis.
Over the last decade, aortic valve replacement with rapid-deployment biological bioprosthesis has become a common alternative technique to mechanical or biological stented valves for high-risk patient...
The incidence of postoperative thrombocytopenia after aortic valve replacement (AVR) with the Perceval S Sutureless bioprosthesis remains unclear. The aim of this study was to report thrombocytopenia ...
Trifecta Aortic Bioprosthesis: Midterm Results in 1,953 Patients from a Single Center.
The St. Jude Medical Trifecta bioprosthesis is a bovine pericardial valve mounted on a titanium stent. The objective of this study was to report a single center experience with the Trifecta aortic val...
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.
