Methods:

The investigators conducted a prospective, multicenter, single-arm study, the TRILUMINATE trial, in 21 sites in Europe and the United States. Patients with moderate or greater TR, New York Heart Association class II or higher heart failure, and who were adequately treated per applicable standards were eligible for enrollment. Patients were excluded if they had systolic pulmonary artery pressure of >60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. TR was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was TR reduction by at least one grade at 30 days post-procedure; the success rate was tested against a prespecified performance goal of 35% using the exact binomial test at a one-sided 2.5% significance level. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups.