NCT06605313

SQ-Kyrin-T First-in-man Feasibility Study

First-in-man Feasibility Study of SQ-Kyrin-T Transcatheter Tricuspid Valve Clip Delivery System and Steerable Guide Catheter in Patients With Severe Tricuspid Regurgitation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery; and to provide safety and efficacy data on which subsequent confirmatory trial can be based.

Detailed description

A prospective, multicenter, single-arm feasibility trial to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery. It plans to enroll 12 qualified patients. The primary endpoint of the study is the postoperative technical success rate. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System	Transcathether Edge-to-Edge repair for tricuspid regurgitation with SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System.

Timeline

• Start date: 2022-06-16
• Primary completion: 2022-12-07
• Completion: 2027-11-24
• First posted: 2024-09-20
• Last updated: 2024-09-20

Locations

1 site across 1 country: China