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NCT01931956 · ClinicalTrials.gov registry record · NA
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 965
- Enrollment target
NCT01931956: Completed NA study, sponsored by Abbott Medical Devices.
NCT01931956 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 965 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01931956, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 965 participants
- Enrollment target
Study Summary
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).
Primary Outcome
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Interventions
- DEVICE MitraClip® implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 965 participants |
| Start Date | 2009-01-22 |
| Est. Completion | 2018-06 |
| Phase | NA |
What the finished NCT01931956 record still lists
NCT01931956 is an interventional study that assigns participants to a tested intervention. The registered 965 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 (31% lower).
The record links to 0 conditions, and to 1 intervention - of which MitraClip® implant is the first listed.
NCT01931956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01931956 about?
NCT01931956 is a clinical study titled "Real World Expanded Multicenter Study of the MitraClip® System (REALISM)". Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01...
What is the current status of trial NCT01931956?
This trial is currently completed. It is a NA study. The enrollment target is 965 participants. The study started on 2009-01-22. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01931956?
The interventions under investigation include: MitraClip® implant (DEVICE).
Who is sponsoring clinical trial NCT01931956?
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 NCT01931956's enrollment target sits among peer trials
965 123rd of 2000 higher than 1,878 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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