ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
Summary
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 effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three (23) sites internationally and in the United States combined enrolled 405 patients. The objective of the study was to evaluate the safety and effectiveness of the ATS 3f(r) Aortic Bioprosthesis Model 1000 equine pericardial prosthesis in a a patient population undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis with or without concomitant procedures.
Addendum: After receiving PMA approval in October of 2008 of the 21mm-29mm sizes, this IDE was expanded to comply with the conditions set forth in the approval notice. Study Protocol S2001 Rev. E is a continuation of the original protocol, but is only enrolling subjects who require a 19mm ATS 3f(r) Aortic Bioprosthesis, Model 1000 and is described as "A multi-center, non-randomized trial, designed to obtain 800 patient years. Each enrolled patient will be followed for a minimum one year and annually thereafter until size 19mm product approval or study cessation. Preoperative, discharge or 30 days (which ever comes last), 3-6 month, and annual follow-up data are required.
Description
The patients for whom ATS Medical, Inc., ATS 3f(r) Aortic Bioprosthesis Model 1000 is intended are those patients whose prognosis without surgery for replacement of the diseased natural valve or previous implanted prosthetic valve is unacceptably poor in terms of survival, quality of life, or both, in the opinion of the attending physicians. For this special subset of patients, there are a number of widely accepted prosthetic heart valves in use.
Study Design
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Heart Valve Diseases
Intervention
ATS 3f(r) Aortic Bioprosthesis, Model 1000
Location
United Hospital
St. Paul
Minnesota
United States
55102
Status
Enrolling by invitation
Source
ATS Medical, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00657826
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
Discrete Subaortic Stenosis
A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.
Clinical Trials
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 isolate...
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (
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.
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe a...
Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position
The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcif...
PubMed Articles
Aims: We describe the first report of an Edwards SAPIEN valve implanted in a tricuspid bioprosthesis from the femoral vein. We highlight the feasibility of this previously avoided approach and the tec...
Our aim was to evaluate the long-term results of implantation of the Carpentier-Edwards pericardial (CEP) valve in the aortic position. Between January 1996 and December 2007, 244 patients who underwe...
Transatrial stent-valve implantation in a stenotic tricuspid valve bioprosthesis.
A 69-year-old man presented with symptoms of right heart failure due to stenosis of a tricuspid valve bioprosthesis. Echocardiography revealed right atrial dilatation and an estimated tricuspid valve...
Prosthetic Valve Endocarditis Caused by Staphylococcus Capitis: Report of 4 Cases.
ABSTRACT: Although Staphylococcus capitis is considered to be a rare causative organism for prosthetic valve endocarditis, we report 4 such cases that were encountered at our hospital over the past 2...
Quadricuspid aortic valve by using intraoperative transesophageal echocardiography.
ABSTRACT: Quadricuspid aortic valve is a rare congenital malformation of the aortic valve. Its diagnosis is often missed even with the use of transthoracic echocardiogram. Many of these patients progr...
