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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Isolated aortic valve replacement with a size 19mm valve
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
McGill University Health Centre
Montreal, Quebec, Canada
NYHA Functional Classification
The NYHA classifications will be analyzed to demonstrate if implanting of the study valve leads to an improvement in this clinical parameter for the patient.
Time frame: 3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA
Blood Data
Blood data will be analyzed preoperatively and postoperatively to deomonstrate if implanting of the study valve results in acceptable parameters for SLDH, Haptoglobin, Hematocrit and Reticulocyte parameters. Platelet and white blood cell count will also be analyzed.
Time frame: 3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA
Cardiovascular Complications
All cardiovascular related complications should be conducted and evaluated according to the STS guidelines. In reporting complications, all cardiovascular related symptoms will be evaluated as to their relation to the valve.
Time frame: 3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA
Hemodynamic Performance
Assessment of hemodynamic performance shall include analysis of Doppler echocardiographic studies at the early and late postoperative evaluations.
Time frame: 3-6 months, 11-14 months, anuually for a minimum of 800 patient years to support a PMA application to the U.S. FDA
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