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NCT00209339 · ClinicalTrials.gov registry record · Phase 1
Feasibility Study of a Percutaneous Mitral Valve Repair System.
A Phase 1 study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT00209339: Completed Phase 1 study, sponsored by Abbott Medical Devices.
NCT00209339 is a Phase 1 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00209339, a Phase 1 study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
Primary Outcome
All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).
Interventions
- DEVICE Percutaneous mitral valve repair (MitraClip Implant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2003-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT00209339 record still lists
NCT00209339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Percutaneous mitral valve repair (MitraClip Implant) is the first listed.
NCT00209339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00209339 about?
NCT00209339 is a clinical study titled "Feasibility Study of a Percutaneous Mitral Valve Repair System.". Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
What is the current status of trial NCT00209339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2003-07. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00209339?
The interventions under investigation include: Percutaneous mitral valve repair (MitraClip Implant) (DEVICE).
Who is sponsoring clinical trial NCT00209339?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00209339's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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