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.
Primary Outcome Measures:
- NYHA Functional Classification [ 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 ] [ Designated as safety issue: No ]
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.
- Blood Data [ 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 ] [ Designated as safety issue: Yes ]
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.
- Cardiovascular Complications [ 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 ] [ Designated as safety issue: Yes ]
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.
- Hemodynamic Performance [ 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 ] [ Designated as safety issue: No ]
Assessment of hemodynamic performance shall include analysis of Doppler echocardiographic studies at the early and late postoperative evaluations.
| Estimated Enrollment: |
8 |
| Study Start Date: |
October 2001 |
| Estimated Primary Completion Date: |
June 2013 (Final data collection date for primary outcome measure) |
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Experimental: ATS 3f(r) Aortic Bioprosthesis, Model 1000
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Device: ATS 3f(r) Aortic Bioprosthesis, Model 1000
Isolated aortic valve replacement
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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.
Purpose
