Edwards Says PASCAL Outperformed Medical Therapy on Tricuspid Trial Endpoint

Edwards Lifesciences said Monday its PASCAL system outperformed medical therapy alone on the CLASP II TR trial’s six-month primary endpoint, with one-year data showing 80% of treated patients had moderate or lower tricuspid regurgitation (TR). Edwards announced the result at 1:25 p.m. ET (18:25 UTC), and the data were presented at TCT 2026.

At one year, 80% of PASCAL-treated patients had TR at moderate severity or lower, compared with 30% of control patients. TR is leakage through the tricuspid valve. PASCAL recipients also had an 18-point improvement on the Kansas City Cardiomyopathy Questionnaire; Edwards gave no corresponding control-group figure.

The trial’s hierarchical primary endpoint combines mortality, durable right ventricular assist device implantation or heart transplant, tricuspid intervention, heart failure hospitalizations and improvement in quality of life. Edwards did not provide an effect size or p-value for the endpoint, or separate results for its components.

The U.S. Food and Drug Administration (FDA) approved PASCAL Precision for tricuspid repair on Oct. 21 for certain patients with symptomatic severe TR despite optimal medical therapy who are at intermediate or greater risk for surgery.