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NCT00657826 · ClinicalTrials.gov registry record · NA
ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
A NA study, sponsored by Medtronic Cardiovascular.
- Terminated
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT00657826: Clinical Trial NA study, sponsored by Medtronic Cardiovascular.
NCT00657826 is a NA study that was terminated before completion, run by Medtronic Cardiovascular. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657826, a NA study, was terminated before completion, sponsored by Medtronic Cardiovascular.
- TERMINATED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2001-10 |
| Est. Completion | 2015-07 |
| Phase | NA |
Why NCT00657826 stopped before completion
NCT00657826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm is the first listed.
NCT00657826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00657826 about?
NCT00657826 is a clinical study titled "ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm". 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 internati...
What is the current status of trial NCT00657826?
This trial is currently terminated. It is a NA study. The enrollment target is 22 participants. The study started on 2001-10. Estimated completion is 2015-07.
What interventions are being tested in trial NCT00657826?
The interventions under investigation include: ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm (DEVICE).
Who is sponsoring clinical trial NCT00657826?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00657826's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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