The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

July 2, 2023 updated by: Jenscare Scientific

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Yunnan Fuwai Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Patients with symptomatic FMR due to ischemic or non-ischemic cardiomyopathy with moderate-severe or greater mitral regurgitation (MR ≥ 3+) confirmed by echocardiography;
  • Patients that have undergone adequate treatment, including treatment for conditions such as coronary artery disease, left ventricular dysfunction, heart failure, and mitral regurgitation (e.g., coronary revascularization, cardiac resynchronization therapy, and/or guideline-directed medication therapy (GDMT) at a stable dose), as judged by the local hospital heart team; Note: Any change in GDMT with ≥ 100% increase or ≥ 50% decrease in dose is considered "unstable".
  • NYHA cardiac function classification ≥ Class II;
  • Left ventricular ejection Fraction (LVEF) ≥ 20%;
  • Left ventricular end systolic diameter (LVESD) ≤ 70 mm;
  • At least one hospitalization for heart failure in the past 12 months and/or after adequate treatment, corrected BNP >150 pg/ml or corrected NT-proBNP > 600 pg/ml (correction method: If the patient has a body mass index (BMI) ≥ 20 kg/m2, BNP or NT-proBNP decreases by 4% for each 1 kg/m2 increase);
  • Subjects with mitral valves anatomically suitable for mitral valve repair using this investigational device;
  • Subjects who fully understand the trial protocol and purpose, voluntarily participate in the trial and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.

Exclusion Criteria:

  • A history of mitral valve surgery or combined valvular disease requiring surgical or interventional treatment;
  • Active rheumatic heart disease, infective endocarditis;dian
  • Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis), constrictive pericarditis;
  • Left intracardiac masses, bulges, thrombi and/or mitral valve leaflets, tendinopathy indicated by imaging;
  • Severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term steroid hormone medication;
  • Severe right heart insufficiency or pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg measured by ultrasound or right heart catheter; if measured at the same time, the right heart catheter measurement shall prevail);
  • Patients who have had an acute myocardial infarction, stroke/transient ischemic attack (TIA) and/or gastrointestinal bleeding within 30 days; Patients who have undergone any transcatheter cardiovascular intervention, carotid artery surgery, pacemaker implantation, cardiac resynchronization therapy (CRT-P, CRT-D) or implantable cardioverter defibrillator (ICD) within 30 days, or cardiovascular surgery within 180 days;
  • Hemodynamic instability, with systolic blood pressure < 90 mmHg in the absence of afterload-reducing drugs, or cardiogenic shock or the need for vasoactive drugs, intra-aortic balloon pump, left ventricular assist devices, etc.;
  • Patients with known bleeding disorders, coagulation disorders, and/or clear contraindications to the use of anticoagulants and antiplatelet agents;
  • Known hypersensitivity to product composition;
  • Patients with clear contraindications to transesophageal echocardiography, contraindications to tracheal intubation, and/or the presence of contraindications to general anesthesia;
  • Modified Rakin score ≥ 4;
  • Patients with a life expectancy of < 12 months or who have undergone a heart transplant or are scheduled to have a heart transplant within 12 months after surgery;
  • Patients who are enrolled in other drug or device clinical trials and have not completed follow-up of the primary endpoint;
  • Pregnant or breastfeeding women or those planning to become pregnant within the next 12 months;
  • Other conditions that the investigator considers inappropriate to participate in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality or hospitalization rate
Time Frame: 12 months
All-cause mortality or hospitalization rate for heart failure 12 months after surgery.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jenscare Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LT-2022-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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