Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System

Inclusion criteria

• Age ≥60, male or female;
• patients with severe or above secondary tricuspid regurgitation (TR≥4+) (secondary tricuspid regurgitation: tricuspid regurgitation caused by right atrial lesions, right ventricular cardiomyopathy, right ventricular myocardial infarction, left ventricular valvular disease, congenital heart disease and other diseases);
• A multidisciplinary cardiac team (at least 2 doctors) consisting of cardiovascular physicians, cardiovascular surgeons, radiologists, anesthesiologists, etc., considered the subject to be at high risk for surgery and expected to benefit from tricuspid valve repair;
• Left ventricular ejection fraction LVEF≥40%;
• The subject voluntarily participates in the clinical trial and agrees or his/her guardian agrees to sign the informed consent.
• Tricuspid regurgitation symptoms, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites;
• NYHA grade 2 to 4;
• Patients who received tricuspid valve optimal drug therapy for ≥ 30 days were in stable condition;
• In the case of the following diseases: mitral regurgitation, atrial fibrillation, coronary disease and heart failure, drug treatment should be ≥ 30 days or ≥ 30 days after instrumental treatment and the patient's condition is stable.

Exclusion criteria

• patients with primary tricuspid regurgitation;
• Patients with systolic pulmonary artery pressure ≥55 mmHg;
• Patients with tricuspid valve or annuloplasty or tricuspid related procedure;
• Patients with posterior tricuspid annulus calcification;
• Evidence of mass, thrombosis or vegetations in the heart, jugular vein and superior vena cava;
• patients with moderate or higher aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
• patients with severely uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
• Percutaneous coronary intervention within 1 month;
• myocardial infarction or known unstable angina within 1 month;
• Cerebrovascular accident within the past 3 months;
• patients with active endocarditis or active rheumatic heart disease;
• Patients with coagulation dysfunction, hypercoagulability or anemia (hemoglobin < 90 g/L);
• patients with acute infection or other severe infection;
• Patients with active peptic ulcer or active gastrointestinal bleeding;
• severe end-stage diseases (such as malignant tumor, severe lung disease, liver disease, renal failure) with a life expectancy of less than one year;
• Patients with known allergies or contraindications to the raw materials or drugs (such as antiplatelet drugs and anticoagulants) of the test products;
• Persons addicted to alcohol, drugs or drugs;
• Patients with cognitive impairment;
• patients with histories of epilepsy or mental illness;
• Participate in any other clinical trial (other than a registry study) within 30 days prior to signing the informed consent;
• have a previous implantation of a pacemaker or defibrillator, or plan to implant a pacemaker or defibrillator;
• Tricuspid stenosis;
• Ebstain syndrome;
• The anatomy of tricuspid annulus could not be assessed by TEE and TTE;
• Hemodynamic instability;
• chronic dialysis patients;
• women who are pregnant during pregnancy, breast-feeding or during the clinical study;
• Other conditions that the investigator considers inappropriate for participation in the clinical trial.