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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Annuloplasty

• Study Type: Interventional
• Enrollment (Anticipated): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: K-clipTM transcatheter annuloplasty system

Device: Transcatheter Annuloplasty; Under echocardiography guidance, the transcatheter tricuspid annuloplasty system precisely reaches the specified position in the tricuspid valve region via jugular vein and superior vena cava approach. The enlarged tricuspid annular tissue is clamped with the clamp cpart and anchor part to reduce the perimeter of tricuspid annulus, so that the area of tricuspid orifice that could not be coapted is reduced. It plays the purpose of minimally invasive treatment of tricuspid valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		1-year after operation
Change of Tricuspid Regurgitation Grade	Change of Tricuspid Regurgitation Grade assessed by corelab than baseline	1-year after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of device implantation		intra-procedure
The success rate of post operation 12 months		2 years, 3years, 4 years, 5 years
Change in echocardiographic parameters	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)。	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
NYHA		1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years
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

Collaborators and Investigators

• Sponsor: Shanghai Huihe Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 15, 2027

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: HH2021003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No