A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System

This is an interventional treatment trial for Degenerative Mitral Valve Disease Read More

Inclusion Criteria:

• Age ≥ 18 years;
• Echocardiographically confirmed moderate-severe or severe degenerative mitral regurgitation (regurgitation degree MR ≥ 3+);
• NYHA Classification II-IV.
• LVEF ≥ 20%
• Patients considered at high surgical risk after evaluation by two or more cardiovascular specialists (American Association for Thoracic Surgery STS score: risk of death from mitral valve repair ≥ 6% or from mitral valve replacement ≥ 8% (high risk); or the presence of 2 or more indices of frailty (moderate to severe frailty); or the presence of 2 or more major organ insufficiencies that do not improve postoperatively; or a comprehensive cardiac team assessment that the patient has other combined diseases or factors that make him or her unsuitable for surgery)
• Anatomically suitable for mitral valve repair and assessed as suitable for use of this investigational device.
• Voluntarily participate and sign an informed consent form and be willing to accept relevant examinations and clinical follow-up.

Exclusion Criteria:

• Severe mitral valve calcification
• Previous implantation of a prosthetic mitral valvuloplasty ring or prosthetic mitral valve, or previous transcatheter mitral valve surgery
• Patients with active infective endocarditis
• Patients with mitral stenosis
• Any intracardiac mass, left ventricular or atrial thrombus detected by echocardiography
• Severe coronary stenosis without surgical or interventional treatment or an acute myocardial infarction within 90 days
• Combined with tricuspid, aortic valve or severe macrovascular pathology requiring surgical or interventional treatment
• Severe 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 with severe right heart insufficiency
• Hemodynamic instability, defined as systolic blood pressure <90 mmHg in the absence of afterload-reducing drugs, cardiogenic shock, or use of intra-aortic balloon pump;
• Had a stroke/transient ischemic attack (TIA) within 30 days or severe carotid stenosis (> 70% stenosis on ultrasonography)
• Have undergone transcatheter cardiovascular intervention (PCI) within 30 days, or cardiovascular surgery within 180 days
• Have had a pacemaker or cardioverter-defibrillator (ICD) implanted, or have undergone cardiac resynchronization therapy (CRT, CRT-D) within 30 days
• Patients with clear coagulation disorders and severe coagulation disorders, or with clear contraindications to the anticoagulant drugs
• Known hypersensitivity to product composition
• Patients with severe neurological pathology affecting cognitive ability
• Patients with a life expectancy of < 12 months
• Have undergone a heart transplant or have recently been allocated a heart transplant donor
• Being enrolled in an interventional clinical study of another device or drug
• Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis), dilated cardiomyopathy, or constrictive pericarditis
• Patients who are pregnant or planning to become pregnant within the next 12 months. Note: Female patients of childbearing age are required to undergo a pregnancy test within 14 days prior to the operation and the result should be negative, and additionally they should use a confirmed method of contraception
• Other conditions that the investigator considers inappropriate for participation in this clinical study