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A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation - Trial NCT05296148

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.

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Trial Details
ClinicalTrials.govNCT05296148
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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

Study Focus

Tricuspid Regurgitation

Transcatheter Tricuspid Valve Implantation

Interventional

device

Sponsor & Location

CroiValve Limited

Gdańsk,Katowice,Warsaw, Poland

Timeline & Enrollment

N/A

Jun 17, 2022

Mar 31, 2025

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 stenosis
Tricuspid stenosis with insufficiency
Nonrheumatic tricuspid (valve) stenosis
Tricuspid insufficiency
Nonrheumatic tricuspid (valve) stenosis with insufficiency

Data Source

ClinicalTrials.gov

NCT05296148

Device Trial