NCT05173233: TriStar

Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System

Not yet recruiting NA Last updated 21 April 2022

What this trial tests

NA trial testing Transcatheter Annuloplasty in Tricuspid Regurgitation in 67 participants. Not yet recruiting.

Timeline

15 May 2022

Primary endpoint
15 May 2023

15 May 2027

Quick facts

Lead sponsor	Shanghai Huihe Medical Technology Co., Ltd
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	15 May 2022
Primary completion	15 May 2023
Estimated completion	15 May 2027

Drugs / interventions tested

• Transcatheter Annuloplasty

Conditions studied

• Tricuspid Regurgitation — all drugs for Tricuspid Regurgitation →

Sponsor

Shanghai Huihe Medical Technology Co., Ltd

Who can join

60 and older, any sex, with Tricuspid Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd. for the treatment of subjects with severe or worse tricuspid regurgitation.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation.
   Xu H, Chen M, Wang Z, Huo J, et al · · 2024 · cited 8× · PMID 39663060 · DOI 10.1016/j.jcin.2024.10.007
2. 30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study.
   Xu H, Li W, Lee AP, Wu S, et al · · 2023 · cited 6× · PMID 38938712 · DOI 10.1016/j.jacadv.2023.100671
3. Transcatheter Tricuspid Annuloplasty in Tricuspid Regurgitation Patients With Right Ventricular-Pulmonary Arterial Uncoupling.
   Lin D, Jin Q, Miao J, Li Z, et al · · 2025 · cited 5× · PMID 40148014 · DOI 10.1016/j.jacasi.2025.01.004
4. Transcatheter annuloplasty with the K-Clip system for tricuspid regurgitation: one-year results from the TriStar study.
   Zhang X, Jin Q, Li W, Pan C, et al · · 2025 · cited 4× · PMID 40028730 · DOI 10.4244/eij-d-24-00591
5. Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation.
   Lin DW, Zou LW, Miao JX, Fan JN, et al · · 2025 · cited 1× · PMID 39997489 · DOI 10.3390/jcdd12020055
6. 30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System : A Single-Center, Observational Study
   Xu H, Li W, Lee A, Wu S, et al · · 2023