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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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Heart Valve Diseases
ATS 3f Enable Aortic Bioprosthesis Model 6000
Medical University of Vienna
ATS Medical, Inc.
Published on BioPortfolio: 2014-07-24T14:05:53-0400
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
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...
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older...
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.
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...
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 ...
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...
Transcatheter aortic valve replacement (TAVR) is not currently approved for pure native valve aortic incompetence, and is typically performed on a compassionate basis in selected patients who are at h...
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.
A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material.
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).
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.
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.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...