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 - Trial NCT05770648
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.
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Study Focus
Sponsor & Location
Shanghai Huihe Medical Technology Co., Ltd
Timeline & Enrollment
N/A
Mar 01, 2023
Dec 01, 2024
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
Data Source
ClinicalTrials.gov
NCT05770648
Device Trial