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NCT05434507

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

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter
Shanghai Huihe Medical Technology Co., Ltd·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Tricuspid Regurgitation
Drug/Device/Intervention
Transcatheter Annuloplasty
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Shanghai Huihe Medical Technology Co., Ltd
Location
Shanghai, China
Timeline & enrollment
Phase
N/A
Start date
Sep 16, 2021
End date
Sep 16, 2026
Enrollment
10 participants
Primary outcome

Success rate 1year after operation,Success rate of operation,Success rate of device implantation,Change in echocardiographic parameters,Change in echocardiographic parameters,Change of Tricuspid Regurgitation Grade,NYHA Functional Class,6 minutes walk distance,Kansas City Cardiomyopathy Questionnaire

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

ICD-10 classifications
Tricuspid stenosisTricuspid stenosis with insufficiencyNonrheumatic tricuspid (valve) stenosisTricuspid insufficiencyNonrheumatic tricuspid (valve) stenosis with insufficiency
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05434507
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05434507 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Huihe Medical Technology Co., Ltd and is currently Recruiting. The study focuses on Tricuspid Regurgitation. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.