The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

NCT05931900 | Unknown

• 1 other identifier: LT-2022-07
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality or hospitalization rate

  All-cause mortality or hospitalization rate for heart failure 12 months after surgery.

  12 months

Study Arms (1)

moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients

EXPERIMENTAL

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

Interventions

moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients DEVICE

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).

moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jenscare Scientific: lead

Study Sites (1)

Yunnan Fuwai Cardiovascular Hospital

Kunming, Yunnan, 650000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 5, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)