The clinical study will enroll approximately 400 patients across 75 sites, utilizing a 2:1 randomization against existing commercial alternatives. To capture a broader range of clinical data, the trial design also includes a single-arm registry for up to 150 patients deemed ineligible for current commercial devices or suboptimal candidates for transcatheter edge-to-edge repair.

Leading the investigation are Dr. Charanjit Rihal of the Mayo Clinic, Dr. Kashish Goel of Vanderbilt University Medical Center, and Dr. Brandon Jones of Providence St. Vincent Medical Center. These physicians, whose institutions were the top enrollers in the earlier feasibility study, view the system as a potential leap forward in treating complex anatomies. Company CEO Ramji Iyer stated that the approval marks a transition toward gathering deeper clinical insights for the estimated 1.6 million patients in the U.S. currently living with tricuspid regurgitation.