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

Shanghai Huihe Medical Technology Co., Ltd0 sites67 target enrollmentMay 15, 2022

ConditionsTricuspid Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tricuspid Regurgitation
Sponsor: Shanghai Huihe Medical Technology Co., Ltd
Enrollment: 67
Primary Endpoint: Change of Tricuspid Regurgitation Grade
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 15, 2022

End Date

May 15, 2027

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Huihe Medical Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥60, male or female;
•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);
•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;
•Left ventricular ejection fraction LVEF≥40%;
•The subject voluntarily participates in the clinical trial and agrees or his/her guardian agrees to sign the informed consent.
•Tricuspid regurgitation symptoms, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites;
•NYHA grade 2 to 4;
•Patients who received tricuspid valve optimal drug therapy for ≥ 30 days were in stable condition;
•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

•patients with primary tricuspid regurgitation;
•Patients with systolic pulmonary artery pressure ≥55 mmHg;
•Patients with tricuspid valve or annuloplasty or tricuspid related procedure;
•Patients with posterior tricuspid annulus calcification;
•Evidence of mass, thrombosis or vegetations in the heart, jugular vein and superior vena cava;
•patients with moderate or higher aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
•patients with severely uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
•Percutaneous coronary intervention within 1 month;
•myocardial infarction or known unstable angina within 1 month;
•Cerebrovascular accident within the past 3 months;

Outcomes

Primary Outcomes

Change of Tricuspid Regurgitation Grade

Time Frame: 1-year after operation

Change of Tricuspid Regurgitation Grade assessed by corelab than baseline

All-cause mortality

Time Frame: 1-year after operation

Secondary Outcomes

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)
Kansas City Cardiomyopathy Questionnaire (KCCQ)(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)