NCT05417945

A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System

A Prospective, Multicenter, Single-group Target Value Clinical Study to Evaluate the Safety and Efficacy of JensClip Transcatheter Valve Repair System in the Treatment of Moderate to Severe Degenerative Mitral Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Jenscare Scientific · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the above clinical trial primary endpoint and secondary endpoint indicators.

Detailed description

Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.Using the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk.

Conditions

• Degenerative Mitral Valve Disease
• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	JensClip transcatheter valve repair system	Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-01
• Completion: 2024-12-01
• First posted: 2022-06-14
• Last updated: 2022-06-14