Real World Expanded Multi-center Study of the MitraClip System (REALISM)
Prospective, multi-center, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Clinical follow-up at discharge, 30 days, 6 months, 12 months, and 2-, 3-, 4-, and 5-years. The study consists of two arms: a high risk group and a non-high risk group. Enrollment in high risk arm is ongoing. Enrollment in non-high risk arm concluded in April 2011.
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||A Continued Access Registry of the Evalve® MitraClip® System: EVEREST II Real World Expanded Multi-center Study of the MitraClip System (REALISM)|
The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's System (MitraClip device). After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) and EVEREST II High Risk Registry Study (HRR), continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm is ongoing.
REALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01931956
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|Baptist Hospital of Miami, FL|
|Miami, Florida, United States, 33176|
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22903|
|Study Director:||Ted Feldman, M.D. Feldman, M.D.||NorthShore University HealthSystem|
|Study Director:||Donald D Glower Jr., MD||Duke University|