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ACTIVE NOT RECRUITING
NCT06021509
NA

Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation

Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd

View on ClinicalTrials.gov

Summary

To validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of moderate to severe and severe degenerative mitral regurgitation (DMR).

Official title: A Prospective, Multicenter, Single-arm Clinical Study of NovoClasp Transcatheter Mitral Valve Clip and Steerable Guide Catheter for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation (DMR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2022-05-15

Completion Date

2028-06-25

Last Updated

2023-09-01

Healthy Volunteers

No

Interventions

DEVICE

NovoClasp® transcatheter mitral valve clip and steerable guide catheter

The experimental device is a class III implanted valve device, which will be used to treat the mitral valve regurgitation via transcatheter edge-to-edge repair.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China