This is a randomized controlled trial comparing the MitraClip device with surgical repair in patients with severe primary mitral regurgitation at moderate surgical risk. Patients must be deemed suitable for mitral valve surgical repair. Subjects are considered to be at moderate surgical risk if at least 75 years of age, OR if younger than 75 years, then has: (1) Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR (2) Presence of other comorbidities which may introduce a potential surgery-specific impediment. 500 patients are to be randomized in parallel fashion to surgical and transcatheter repair.
There are two primary outcomes. The first primary outcome is the composition of all-cause mortality, stroke, cardiac hospitalization (excluding the first 30 days) and renal replacement therapy at 2 years. The second primary outcome is the proportion of patients with moderate or less MR, without mitral valve replacement and without recurrent mitral valve intervention at 2 years. The outcomes assessor is blinded to treatment arm. Study was started July 21st 2020 and estimated primary completion date is February 2024.