 Upon completion of enrollment in the HRR, a process was initiated to ensure patient consent to participate in a Concurrent Control CC group was in place. Patients were identified to determine survival through 12 months with current standard of care treatment.CC patients were derived from a cohort of patients screened for enrollment in the HRR,yet did not enroll. All patients had moderate-to-severe 3 or severe 4 MR based on transthoracic echocardiography TTE. To be considered eligible for inclusion in the CC group, the patient had to be classified as high surgical risk using the same criteria used for the HRR. Upon follow-up with the clinical sites, it was determined that some of the initially identified patients with moderate-to-severe 3 or severe 4 MR met the criteria for high surgical risk. Of these patients, some were not included due to; lack of Institutional Review Board IRB approval at the site, lack of informed consent and unable to be contacted. The remaining patients make up the CC group. 