Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System

Launched by SHANGHAI HUIHE MEDICAL TECHNOLOGY CO., LTD · Jun 26, 2022

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ClinConnect Summary

This clinical trial is testing a new treatment method for a heart condition called tricuspid regurgitation, where the heart's tricuspid valve does not close properly, causing blood to flow backward. The researchers are looking at a device called the K-Clip™ Transcatheter Annuloplasty System, which is designed to help repair the valve without traditional surgery. This study aims to determine how safe and effective this treatment is for patients who are at high risk for surgery and have moderate to severe tricuspid regurgitation.

To be eligible for this trial, patients must be 60 years or older and have been diagnosed with moderate to severe tricuspid regurgitation. They should also have normal heart function and be considered high-risk for surgery. Participants will receive the new treatment and will be closely monitored to assess its effects. It’s important to note that individuals with certain other heart conditions or serious health issues may not qualify for this study. If you or a loved one is interested in participating, the research team will provide detailed information and support throughout the process.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 60 or older, regardless of gender;
• • 2. Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
• • 3. The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. \[No. of experts in cardiovascular surgery \>=2\]) considers the subjects to be at high risk for surgical operation (STS score \> 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair;
• • 4. Patient with normal left ventricular function (LVEF≥40%);
• • 5. The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.
• Exclusion Criteria:
• • 1. Patients with pulmonary artery systolic pressure ≥55 mmHg;
• • 2. Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
• • 3. Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
• • 4. Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
• • 5. Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
• • 6. Received PCI less than 1 month ago;
• • 7. MI happened or UAP was found less than 1 month ago;
• • 8. CVA occurred less than 3 months ago;
• • 9. Patients with comorbid active endocarditis or active RHD;
• • 10. Patients with coagulation disorder, hypercoagulable state or anemia (HGB \< 90 g/L);
• • 11. Patients with acute infection or other severe infections;
• • 12. Patients with active peptic ulcer or active gastrointestinal bleeding;
• • 13. Patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year;
• • 14. Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
• • 15. People who are addicted to alcohol, drugs or narcotics;
• • 16. Patients with cognitive impairment who cannot cooperate with the study or follow-up;
• • 17. Those with a history of epilepsy or mental illness;
• • 18. Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
• • 19. Other situations that the investigator considers inappropriate for participation in this clinical trial.