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

Launched by SHANGHAI HUIHE MEDICAL TECHNOLOGY CO., LTD · Dec 27, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients with severe tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close properly, causing blood to flow backward. Researchers want to see if the K-Clip™ Transcatheter Annuloplasty System, a device designed to help fix this issue, is safe and effective. The trial is not yet recruiting participants but aims to help those who are at high risk for surgery and have not responded well to medication.

To be eligible for this trial, participants must be at least 60 years old and have been diagnosed with severe tricuspid regurgitation. They should show symptoms like shortness of breath or swelling in the legs and must have a stable health condition. Participants will be closely monitored by a team of heart specialists throughout the study. It's important to note that certain health conditions and recent medical events may prevent someone from joining the trial. If you or a loved one might be interested, it’s a good idea to discuss this with a healthcare provider for more personalized information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥60, male or female;
• • 2. 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);
• • 3. 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;
• • 4. Left ventricular ejection fraction LVEF≥40%;
• • 5. The subject voluntarily participates in the clinical trial and agrees or his/her guardian agrees to sign the informed consent.
• • 6. Tricuspid regurgitation symptoms, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites;
• • 7. NYHA grade 2 to 4;
• • 8. Patients who received tricuspid valve optimal drug therapy for ≥ 30 days were in stable condition;
• • 9. 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:
• • 1. patients with primary tricuspid regurgitation;
• • 2. Patients with systolic pulmonary artery pressure ≥55 mmHg;
• • 3. Patients with tricuspid valve or annuloplasty or tricuspid related procedure;
• • 4. Patients with posterior tricuspid annulus calcification;
• • 5. Evidence of mass, thrombosis or vegetations in the heart, jugular vein and superior vena cava;
• • 6. patients with moderate or higher aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
• • 7. patients with severely uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
• • 8. Percutaneous coronary intervention within 1 month;
• • 9. myocardial infarction or known unstable angina within 1 month;
• • 10. Cerebrovascular accident within the past 3 months;
• • 11. patients with active endocarditis or active rheumatic heart disease;
• • 12. Patients with coagulation dysfunction, hypercoagulability or anemia (hemoglobin \< 90 g/L);
• • 13. patients with acute infection or other severe infection;
• • 14. Patients with active peptic ulcer or active gastrointestinal bleeding;
• • 15. severe end-stage diseases (such as malignant tumor, severe lung disease, liver disease, renal failure) with a life expectancy of less than one year;
• • 16. Patients with known allergies or contraindications to the raw materials or drugs (such as antiplatelet drugs and anticoagulants) of the test products;
• • 17. Persons addicted to alcohol, drugs or drugs;
• • 18. Patients with cognitive impairment;
• • 19. patients with histories of epilepsy or mental illness;
• • 20. Participate in any other clinical trial (other than a registry study) within 30 days prior to signing the informed consent;
• • 21. have a previous implantation of a pacemaker or defibrillator, or plan to implant a pacemaker or defibrillator;
• • 22. Tricuspid stenosis;
• • 23. Ebstain syndrome;
• • 24. The anatomy of tricuspid annulus could not be assessed by TEE and TTE;
• • 25. Hemodynamic instability;
• • 26. chronic dialysis patients;
• • 27. women who are pregnant during pregnancy, breast-feeding or during the clinical study;
• • 28. Other conditions that the investigator considers inappropriate for participation in the clinical trial.