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NCT01116037 · ClinicalTrials.gov registry record · NA
ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study
A NA study, sponsored by Medtronic Cardiovascular.
- Terminated
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT01116037: Clinical Trial NA study, sponsored by Medtronic Cardiovascular.
NCT01116037 is a NA study that was terminated before completion, run by Medtronic Cardiovascular. The registered enrollment target is 26 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
NCT01116037, a NA study, was terminated before completion, sponsored by Medtronic Cardiovascular.
- TERMINATED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (\</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.
Primary Outcome
Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.
Interventions
- DEVICE ATS 3f Aortic Bioprosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-11 |
| Phase | NA |
Why NCT01116037 stopped before completion
NCT01116037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 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 is the first listed.
NCT01116037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116037 about?
NCT01116037 is a clinical study titled "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 (\</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed ...
What is the current status of trial NCT01116037?
This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2009-09. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01116037?
The interventions under investigation include: ATS 3f Aortic Bioprosthesis (DEVICE).
Who is sponsoring clinical trial NCT01116037?
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 NCT01116037's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 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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