CMDE releases the Technical Review Points for Clinical Trials of Transcatheter Tricuspid Valve Replacement and Repair Systems (Announcement No. 33 of 2026)

The NMPA's Center for Medical Device Evaluation  released on October 27, 2026, the Technical Review Points for Clinical Trials of Transcatheter Tricuspid Valve Replacement and Repair Systems (Announcement No. 33 of 2026). The document is intended to guide applicants in conducting clinical trials of transcatheter tricuspid valve replacement and repair systems and to provide reference for technical review of clinical evaluation materials. It is a guidance document and is not legally mandatory; applicants should determine applicability based on product characteristics and provide rationale and scientific evidence where a provision is not applicable.

The scope covers conventionally designed transcatheter tricuspid valve replacement and repair systems, including transcatheter artificial tricuspid valves and delivery systems, tricuspid clips and delivery systems, with classification code 13-07-06 and Class III management. The clinical setting is severe tricuspid regurgitation in patients who do not require concomitant left-sided valve surgery, are over 65, have failed optimal medical therapy, and are assessed by a heart team as suitable for tricuspid replacement or repair.

For clinical trials, products with entirely new materials, designs, or structures should undergo feasibility studies, preferably prospective small-sample studies generally of 10–30 cases with appropriate follow-up. Confirmatory trials should use a randomized controlled superiority design against optimal medical therapy for efficacy, while safety may use a single-arm objective performance criteria design. The primary efficacy endpoint is a 12-month composite: the proportion of patients free from all-cause death and heart-failure rehospitalization who also achieve TR reduction of at least one grade, KCCQ improvement, NYHA improvement, and ≥30 m improvement in 6-minute walk distance from baseline. Primary safety endpoints include the 30-day major adverse event (MAE) rate in the treatment group and 12-month all-cause mortality. Sample size should be calculated separately for primary safety and efficacy endpoints and then combined; primary efficacy follow-up is 12 months, and primary safety follow-up is 30 days and 12 months.

For the tricuspid intervention field, these review points provide clearer regulatory reference for trial design, endpoint selection, and sample size estimation.