Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Public ClinicalTrials.gov record NCT01931956. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multicenter Study of the MitraClip System (REALISM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01931956
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 965 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 22, 2009 (Actual)
- Primary completion
- Feb 2015 (Actual)
- Completion
- Jun 2018 (Actual)
- Last update posted
- Dec 4, 2018
2009 – 2018
United States locations
- U.S. sites
- 38
- U.S. states
- 26
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| El Camino Hospital | Mountain View | California | 94040 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Baptist Hospital of Miami, FL | Miami | Florida | 33176 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| St. Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Evanston Hospital | Evanston | Illinois | 60201 | — |
| The Care Group Medical Center (St. Vincent Hospital) | Indianapolis | Indiana | 46290 | — |
| Shawnee Mission Medical Center | Shawnee Mission | Kansas | 66204 | — |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| St. Patrick's Hospital & Health Science Center | Missoula | Montana | 59802 | — |
| Morristown Memorial Hospital | Morristown | New Jersey | 07960 | — |
| New York University Medical Center | New York | New York | 10016 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| New York Presbyterian Hospital | New York | New York | 10032 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Carolina's Medical Center (Sanger Clinic) | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina Heart Institute | Greenville | North Carolina | 27834 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Baylor University Medical Center | Dallas | Texas | 75226 | — |
| Memorial Hermann Hospital | Houston | Texas | 77024 | — |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01931956, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2018 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01931956 live on ClinicalTrials.gov.