Functional Mitral Regurgitation Clinical Trial
Official title:
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
Verified date | June 2023 |
Source | Jenscare Scientific |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 129 |
Est. completion date | August 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Yunnan Fuwai Cardiovascular Hospital | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
Jenscare Scientific |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality or hospitalization rate | All-cause mortality or hospitalization rate for heart failure 12 months after surgery. | 12 months |
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