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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 is a NA study that was terminated before completion, run by Medtronic Cardiovascular. The registered enrollment target is 22 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00657826
The ClinicalTrials.gov registry entry for NCT00657826 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm is the first listed.
NCT00657826 reports 0 study locations.
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.
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