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Real World Expanded Multicenter Study of the MitraClip System (REALISM)

Objective

Prospective, multi-center, randomized study of the Evalve Inc., Cardiovascular Valve Repair System (MitraClip® implant) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month and 12-month clinical follow-up of the primary endpoints, and then annually for up to 5 years post procedure.

All Other Trials

  • Heart & Circulation
Contact
Kelly Jones at 303-724-6473
Eligibility and Other Participant Information

Key Inclusion/Exclusion Criteria

Patients who have been diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), who are seeking treatment for their condition and who at least:

  • Symptomatic
  • If asymptomatic, must have evidence of left ventricular dysfunction
  • Are 18 years or older.
  • Are candidates for mitral valve surgery.
  • Do not have an active peptic uler (a hole in the lining of the stomach, the duodenum - first part of the small intestine - or the esophagus, the tube that connects the throat to the stomach), nor have experienced bleeding in the upper gastro-intestinal tract, within the last six months.
  • Do not require dialysis (process of cleansing the blood, by passing it through a machine).
  • Do not have a history of intravenous drug abuse (drugs injected into the veins).
  • Do not have allergies or hypersensitivity to aspirin, heparin (anti-blood-clotting medication), Ticlid (anti-blood-clotting medication) , Plavix (anti-blood-clotting medication), or contrast media (dye used in X-rays).
  • Appropriate valve anatomy