Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06467110
NA

Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation

Sponsor: Shanghai Shenqi Medical Technology Co., Ltd

View on ClinicalTrials.gov

Summary

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.in patients with moderate-severe or severe degenerated mitral regurgitation (DMR).

Official title: A Prospective, Multicenter, Single-Arm Clinical Trial to Assess the Safety and Efficacy of a Transcatheter Mitral Valve Clip Delivery System With Steerable Guide Catheter in Patients With Moderate-Severe or Severe Degenerative Mitral Regurgitation (DMR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2021-10-15

Completion Date

2028-12-15

Last Updated

2024-06-20

Healthy Volunteers

No

Interventions

DEVICE

transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)

The principle of this product is the transcatheter interventional edge-to-edge repair technology (edge-to-edge repair). The core technology is to treat the regurgitation by edge-to-edge suturing the mitral valve. The double holes are set in the mitral valve (A2/P2 zone) or the edges in A1/P1 or A3/P3 zones are apposed and closed to treat regurgitation.

Locations (1)

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, China