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NCT05770648

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation

Shanghai Huihe Medical Technology Co., Ltd·ClinicalTrials.gov·device·Device trialNot yet recruiting
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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
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2023
End date
Dec 01, 2024
Enrollment
64 participants
Primary outcome

The percentage of subjects with no all-cause death, no heart failure readmitted, NYHA increased by one grade or more, and TR decreased ≥1+ within 6 months after randomization.

Summary

To evaluate the efficacy and safety of the transcatheter tricuspid valve ring system produced
 by Shanghai Huihe Medical Technology Co., Ltd. in the treatment of patients with severe or
 above tricuspid regurgitation who cannot be evaluated by clinicians for surgery.

ICD-10 classifications
Tricuspid stenosisTricuspid stenosis with insufficiencyNonrheumatic tricuspid (valve) stenosisTricuspid insufficiencyNonrheumatic tricuspid (valve) stenosis with insufficiency
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05770648
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05770648 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Huihe Medical Technology Co., Ltd and is currently Not yet recruiting. The study focuses on Tricuspid Regurgitation. Target enrollment is 64 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.