Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 965 participants.
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).
Interventions
- DEVICE MitraClip® implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 965 participants |
| Start Date | 2009-01-22 |
| Est. Completion | 2018-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01931956
The ClinicalTrials.gov registry entry for NCT01931956 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 965 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 1 intervention - of which MitraClip® implant is the first listed.
NCT01931956 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.