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Clinical Trial

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

NCT: NCT07660185 · NOT_YET_RECRUITING

NCT IDNCT07660185
StatusNOT_YET_RECRUITING
Start Date2027-03-01
Completion2032-08-31
SponsorShenzhen Lifevalve Medical Scientific Co., Ltd. (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation is a clinical trial registered under NCT07660185. Current status: NOT_YET_RECRUITING.

What is the status of NCT07660185?

The current status of NCT07660185 (A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation) is: NOT_YET_RECRUITING.

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

A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation started on 2027-03-01.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.