CLASP II TR: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

CLASP II TR

Paciente / Población Intervención / Exposición Comparación Desenlace

In patients with tricuspid regurgitation, transcatheter tricuspid repair with the PASCAL system was superior to medical therapy alone for the six-month primary endpoint.

N

1270pacientes

Diseño

Prospective, multicentre randomised pivotal trial (Edwards; 79 sites in the US and Canada) of transcatheter tricuspid repair with the PASCAL system plus optimal medical therapy versus medical therapy alone; a single-arm registry and a continued-access arm run alongside

Desenlace

Composite of all-cause death, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalisation and quality-of-life improvement (KCCQ). TCT presents clinical and health-status outcomes

ResultadoThe PASCAL system was superior to medical therapy alone for the six-month primary endpoint; no arm values, effect size, 95% CI or P were reported. Among patients treated with PASCAL, 80% achieved moderate or less TR at 1 year vs 30% in the control group. Patients treated with PASCAL showed an 18-point improvement in quality of life on the Kansas City Cardiomyopathy Questionnaire. Adverse event rates at 30 days were described as low, with no figures.

CLASP II TR investigators. Presented at TCT 2026, 2 November. Edwards Lifesciences press release. Not yet published.

Discusión y crítica

The release claims superiority over medical therapy alone for the six-month primary endpoint but gives no effect size, confidence interval, P value or arm values, so the size of the benefit cannot be judged. It also gives no patient numbers, and it does not define the endpoint. The 18-point quality-of-life gain has no stated time point or comparison with the control arm, and safety is described only as low adverse event rates at 30 days, with no figures. These are sponsor-reported headline results pending a full publication.