NCT05040074

SQ-Kyrin TMVr FIM Study

SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.

Detailed description

This is a prospective, multicenter, single-arm observation, feasibility clinical study that plans to enroll a total of not less than 10 and not more than 30 patients, adopts the post-op immediate technical success rate as the primary endpoint, and uses the all-cause mortality at 30 days post-op, incidence of serious adverse event at 30 days post-op, device success rate at 30 days post-op, and procedural success rate at 30 days post-op as secondary endpoints to evaluate the effectiveness, safety, and feasibility of the Transcatheter Edge-to-Edge Valve Repair System of Shanghai Shenqi Medical Technology Co., Ltd. in clinical use and preliminarily evaluate the product's performance. A phasic study report (for phasic data summary and analysis) will be issued after completion of the 30-day postoperative follow-up to evaluate the effectiveness, safety, and feasibility of the device and apply for clinical studies before official registration and marketing. In the meantime, patients enrolled will continue to be followed up for 6 months and 1-5 years post-op to evaluate the long-term effect of the mitral valve repair system.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System	Transesophageal echocardiography-guided, implantable mitral valve clip repair system

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-10-01
• Completion: 2026-10-01
• First posted: 2021-09-10
• Last updated: 2021-09-10

Locations

1 site across 1 country: China