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NCT05296148

A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

A European Feasibility Study of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
CroiValve Limited·ClinicalTrials.gov·device·Device trialRecruiting
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Study focus
Disease/Condition
Tricuspid Regurgitation
Drug/Device/Intervention
Transcatheter Tricuspid Valve Implantation
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
CroiValve Limited
Location
Gdańsk,Katowice,Warsaw, Poland
Timeline & enrollment
Phase
N/A
Start date
Jun 17, 2022
End date
Mar 31, 2025
Enrollment
10 participants
Primary outcome

Freedom from device or procedure related serious adverse events

Summary

This study is prospective, multicentre, non-randomized single-arm early feasibility study to
 evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation
 Valve System in patients with severe 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
NCT05296148
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05296148 through Pure Global AI's free database. This phase not specified trial is sponsored by CroiValve Limited 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.