Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

Shanghai Huihe Medical Technology Co., Ltd1 site in 1 country10 target enrollmentSeptember 16, 2021

ConditionsTricuspid Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tricuspid Regurgitation
Sponsor: Shanghai Huihe Medical Technology Co., Ltd
Enrollment: 10
Locations: 1
Primary Endpoint: Change in echocardiographic parameters
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 16, 2021

End Date

September 16, 2026

Last Updated

3 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

•Aged 60 or older, regardless of gender;
•Patients with moderate-severe or worse tricuspid regurgitation (TR≥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;
•Patient with normal left ventricular function (LVEF≥40%);
•The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.

Exclusion Criteria

•Patients with pulmonary artery systolic pressure ≥55 mmHg;
•Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
•Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
•Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
•Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
•Received PCI less than 1 month ago;
•MI happened or UAP was found less than 1 month ago;
•CVA occurred less than 3 months ago;
•Patients with comorbid active endocarditis or active RHD;
•Patients with coagulation disorder, hypercoagulable state or anemia (HGB \< 90 g/L);