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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05173233
• Lead Sponsor: Shanghai Huihe Medical Technology Co., Ltd

Brief Summary

The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd. for the treatment of subjects with severe or worse tricuspid regurgitation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2021-12-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-21
• Study Start: 2022-05-15
• Primary Completion: 2023-05-15
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 67

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.

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
Change of Tricuspid Regurgitation Grade	1-year after operation	Change of Tricuspid Regurgitation Grade assessed by corelab than baseline
All-cause mortality	1-year after operation

Secondary Outcome Measures

Name	Time	Method
The success rate of post operation 12 months	2 years, 3years, 4 years, 5 years
Success rate of device implantation	intra-procedure
NYHA	1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years
Change of Tricuspid Regurgitation Grade	1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years
Change in echocardiographic parameters	1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years	Change in echocardiographic parameters：Tricuspid annulus A-P diameter（mm）、 Tricuspid annulus perimeter（mm）、Tricuspid annulus area(cm2)、Vena contracta width（mm）、EROA(cm2)、Regurgitation volume(ml)、IVC(mm)。
6 minutes walk distance	1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years
Kansas City Cardiomyopathy Questionnaire (KCCQ)	1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years