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A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation

NCT07660185 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-06-22

No results posted yet for this study

Summary

Shenzhen Lifevalve Medical Scientific Co., Ltd. has developed a new X-Clip Mitral Valve Clip System and its compatible Steerable Guide System, aiming to provide transcatheter mitral valve repair for patients with degenerative mitral regurgitation. The two systems have completed all preclinical tests, including design verification tests, biological evaluation, and animal studies. All the test results confirmed that the systems met relevant design requirements. A First-in-Man clinical study was conducted in China in 2023, involving 11 patients. The study provides initial evidence that the X-Clip Mitral Valve Clip System and Steerable Guide System demonstrate favourable safety and efficacy in the treatment of mitral regurgitation in the Chinese population. The device is currently undergoing a pivotal clinical trial in China.

This study is a clinical study aimed to evaluate the safety and performance of the X-Clip Mitral Valve Clip System and Steerable Guide System in European population.

Conditions

  • Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation

Interventions

DEVICE

X-Clip Treatment for Degenerative Mitral Regurgitation

Adult patients with moderate-to-severe or severe primary/degenerative mitral regurgitation (MR ≥3+) undergoing transcatheter mitral valve repair using the X-Clip Mitral Valve Clip System.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    collaborator INDUSTRY

  • Shenzhen Lifevalve Medical Scientific Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ignacio Cruz González, Professor, MD, PhD · University of Salamanca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2028-05-31
Completion
2032-08-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT07660185 on ClinicalTrials.gov