Real World Expanded Multicenter Study of the MitraClip System (REALISM)
Heart & Circulation
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.
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:
•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