Valvular & structural heart diseaseTrial design
Design and Rationale of the CLASP II Tricuspid Regurgitation (TR) Randomized Trial for Severe Tricuspid Regurgitation
- prospective, multicenter, open-label randomized trial
- 2:1 ratio (device:control)
- central screening committee assessment
- design and rationale; results not yet reported
Study context
- Population
- Symptomatic severe TR patients with ≥severe TR as assessed by an independent echocardiographic core laboratorypatients randomized (planned total, enrollment completed)
- Participants
- 450 patients
- Planned comparison
- device group vs control group
- Primary endpoint
- Hierarchical composite of:
- All-cause mortality
- Durable right ventricular assist device or heart transplant
- Elective or non-elective tricuspid valve surgery/intervention and number of heart failure hospitalization (HFH)
- With quality-of-life improvement assessed using Kansas City Cardiomyopathy Questionnaire Overall Summary score
- Follow-up
- 6 months
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Trial conduct
- The trial has completed enrollment, and the report of primary results is expected
- Crossover of control patients permitted after the 2-year visit or when the last randomized patient completes 12-month follow-up
- Follow-up at baseline; 30 days; 3, 6, and 12 months; and annually through 5 years
Original publication
Design and Rationale of the CLASP II TR Randomized Trial for Severe Tricuspid Regurgitation. Am Heart J. Published 9 October 2026. doi:10.1016/j.ahj.2026.107627
Summarised from the published abstract; every number is checked against it