NCT06021509

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

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This trial is a prospective multi-center single-arm confirmatory study. A total of 102 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo mitral edge-to-edge repair using the NovoClasp® transcatheter mitral valve clip system and steerable guide catheter for the treatment of moderate to severe or severe degenerative mitral regurgitation (DMR). Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days, and 360 days postoperatively. The primary endpoint will be the treatment effectiveness rate at 360 days post-surgery. Secondary endpoint measures include treatment effectiveness at other time points, surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverse events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the NovoClasp® transcatheter mitral valve clip and steerable guide catheter produced by Enlight Medical Technologies (Shanghai) Co., Ltd..

Conditions

• Degenerative Mitral Valve Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-15
• Primary completion: 2024-06-25
• Completion: 2028-06-25
• First posted: 2023-09-01
• Last updated: 2023-09-01

Locations

1 site across 1 country: China