Design and Rationale of the CLASP II TR Randomized Trial for Severe Tricuspid Regurgitation.

Abstract

Severe tricuspid regurgitation (TR) is a progressive disease associated with mortality, heart failure hospitalization (HFH), impaired functional status, and reduced quality of life. Transcatheter tricuspid valve repair and replacement therapies have expanded treatment options for TR patients beyond medical therapy and surgery and improved their functional status and symptoms. The CLASP II TR trial is a prospective, multicenter, open-label randomized trial designed to test superiority of tricuspid transcatheter edge-to-edge repair (T-TEER) with the PASCAL transcatheter valve repair system+optimal medical therapy (device group) versus optimal medical therapy alone (control group) in symptomatic severe TR patients. A total of 450 patients with ≥severe TR as assessed by an independent echocardiographic core laboratory are randomized following central screening committee assessment in a 2:1 ratio (device:control). The primary endpoint is a 6-month hierarchical composite combining key safety and efficacy outcomes (all-cause mortality, durable right ventricular assist device or heart transplant, elective or non-elective tricuspid valve surgery/intervention and number of HFH) with quality-of-life improvement assessed using Kansas City Cardiomyopathy Questionnaire Overall Summary score. Additionally, clinical, echocardiographic, functional, and quality-of-life parameters are also evaluated. Patients are assessed at baseline; 30 days; 3, 6, and 12 months; and annually through 5 years. Crossover of control patients is permitted either after the 2-year visit or when the last randomized patient completes 12-month follow-up. The CLASP II TR trial will inform the safety and effectiveness of the PASCAL system compared to medical therapy alone in the treatment of patients with symptomatic, severe tricuspid regurgitation. The trial has completed enrollment, and the report of primary results is expected. Trial Registration: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR); NCT04097145; https://clinicaltrials.gov/study/NCT04097145.