NCT05931900

The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

A Prospective, Multicenter, Single Group Target Value Study for Evaluating the Safety and Effectiveness of JensClip Transcatheter Valve Repair System in The Treatment of Functional Mitral Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Jenscare Scientific · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of the JensClip transcatheter valve repair system for patients with moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) who have received adequate treatment but are still symptomatic.

Detailed description

The clinical trial study is designed as a prospective, multicenter, single-group target-value clinical study with single-armed target value. Subjects are patients with moderate-severe or greater (MR ≥ 3+) FMR who have received adequate treatment but are still symptomatic. The safety and efficacy of the investigational product and its performance are evaluated using the above clinical trial primary endpoint and secondary endpoint indicators. All subjects in this study will be followed up at 30 days, 3 months, 6 months, and 12 months after device implantation, and clinical data obtained will be analyzed and summarized, and clinical reports will be used for submission for product registration. The study will continue to follow up subjects for 2-5 years after surgery to observe the occurrence of adverse events and to make an accurate and credible evaluation of the long-term safety and efficacy of this investigational product. All relevant clinical data will be collected, organized and statistically analyzed by an independent data management and statistics center and clinical monitoring organization. The core laboratory assesses the relevant imaging data during the clinical trial, and the CEC (Clinical Event Committee) is specially established to determine the endpoint events of the clinical trial. The clinical study consists of two phases: the first phase is a feasibility (FIM) clinical trial and the second phase is a confirmatory clinical trial; the sample size of the FIM clinical trial is not included in the second phase.

Conditions

• Functional Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients	Functional mitral regurgitation (FMR) is common in patients with myocardial infarction or dilated cardiomyopathy, and portends a poor prognosis despite guideline-directed medical therapy (GDMT).

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2023-07-05
• Last updated: 2023-07-05

Locations

1 site across 1 country: China