The JensClip Transcatheter Valve Repair System for Treating Functional

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05931900
Study type	Interventional
Source	Jenscare Scientific
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	August 2023
Completion date	August 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms