SQ-Kyrin TMVr FIM Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05040074
Study type	Interventional
Source	Shanghai Shenqi Medical Technology Co., Ltd
Contact	Grace Gu
Phone	13636491192
Email	guchaojun@sqmedical.com
Status	Recruiting
Phase	N/A
Start date	April 1, 2021
Completion date	October 2026

View Details

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