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

Not Applicable

Recruiting

• Conditions: Tricuspid Regurgitation
• Interventions: Device: Transcatheter Annuloplasty

• Registration Number: NCT05434507
• Lead Sponsor: Shanghai Huihe Medical Technology Co., Ltd

Brief Summary

Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-16
• Status Verified: 2022-06
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-26
• Last Update Submitted: 2022-06-26
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Primary Completion: 2026-09-16
• Study Completion: 2026-09-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
K-clipTM transcatheter annuloplasty system	Transcatheter Annuloplasty	-

Primary Outcome Measures

Name	Time	Method
Success rate 1year after operation	1-year after operation
Success rate of device implantation	intra-procedure
Change in echocardiographic parameters	30 days, 6 Months, 12 Months, annual for five years	Tricuspid annulus area(mm2)
Success rate of operation	intra-procedure
6 minutes walk distance	1 month, 6 months,12 Months	Increase in distance (m) from baseline
NYHA Functional Class	30 days, 6 Months, 12 Months, annual for five years	Number of patients with improvement in NYHA class
Change of Tricuspid Regurgitation Grade	30 days, 6 Months, 12 Months, annual for five years	Number of patients with reduction in TR from baseline
Kansas City Cardiomyopathy Questionnaire	30 days, 6 Months, 12 Months	Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire

Trial Locations

Locations (1)

Shanghai Huihe Healthcare Tecnology Co.,Ltd.; 🇨🇳 Shanghai, Shanghai, China