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NCT00209274 · ClinicalTrials.gov registry record · NA
Pivotal Study of a Percutaneous Mitral Valve Repair System
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 279
- Enrollment target
NCT00209274 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 279 participants.
The verdict
NCT00209274, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 279 participants
- Enrollment target
Study Summary
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
Interventions
- DEVICE Percutaneous mitral valve repair using MitraClip implant
- PROCEDURE Mitral valve repair or replacement surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2005-08 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00209274
The ClinicalTrials.gov registry entry for NCT00209274 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Percutaneous mitral valve repair using MitraClip implant is the first listed.
NCT00209274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00209274 about?
NCT00209274 is a clinical study titled "Pivotal Study of a Percutaneous Mitral Valve Repair System". EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-cente...
What is the current status of trial NCT00209274?
This trial is currently completed. It is a NA study. The enrollment target is 279 participants. The study started on 2005-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00209274?
The interventions under investigation include: Percutaneous mitral valve repair using MitraClip implant (DEVICE), Mitral valve repair or replacement surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00209274?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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