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.
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