Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Completed · Not applicable
Conditions studied: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
In brief
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).
Key facts
- Study ID
- NCT01931956
- Run by
- Abbott Medical Devices
- People needed
- 965
- Starts
- 2009-01-22
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2018-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- El Camino Hospital — Mountain View, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- University of Colorado Health Sciences Center — Aurora, Colorado, United States
- Washington Hospital Center — Washington D.C., District of Columbia, United States
- Baptist Hospital of Miami, FL — Miami, Florida, United States
- Piedmont Hospital — Atlanta, Georgia, United States
- St. Joseph's Hospital — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Evanston Hospital — Evanston, Illinois, United States
- The Care Group Medical Center (St. Vincent Hospital) — Indianapolis, Indiana, United States
- Shawnee Mission Medical Center — Shawnee Mission, Kansas, United States
- Terrebonne General Medical Center — Houma, Louisiana, United States
- Maine Medical Center — Portland, Maine, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
- Minneapolis Heart Institute — Minneapolis, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- St. Patrick's Hospital & Health Science Center — Missoula, Montana, United States
- Morristown Memorial Hospital — Morristown, New Jersey, United States
- New York University Medical Center — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- New York Presbyterian Hospital — New York, New York, United States
- Lenox Hill Hospital — New York, New York, United States
- St. Francis Hospital — Roslyn, New York, United States
- Carolina's Medical Center (Sanger Clinic) — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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