Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Abbott Medical Devices.
NCT00209274 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 279 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
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 |
What the finished NCT00209274 record still lists
NCT00209274 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Percutaneous mitral valve repair using MitraClip implant is the first listed.
NCT00209274 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00209274's enrollment target sits among peer trials
279 381st of 2000 higher than 1,619 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04783857 · 279 participants · Phase 4
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
- NCT05407324 · 279 participants · Phase 2
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
- NCT06299748 · 279 participants
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
- NCT06582784 · 279 participants · NA
IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia