| 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.
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