The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation

Launched by JENSCARE SCIENTIFIC · Jul 2, 2023

Keywords

ClinConnect Summary

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 ...

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Eligibility criteria

• 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.