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

NCT06021509 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-09-01

No results posted yet for this study

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).

Conditions

  • Degenerative Mitral Valve Disease

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.

Sponsors & Collaborators

  • Enlight Medical Technologies (Shanghai) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2024-06-25
Completion
2028-06-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06021509 on ClinicalTrials.gov