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A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

NCT05296148 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Transcatheter Tricuspid Valve Implantation

Implantation of a tricuspid coaptation valve through a transcatheter approach.

Sponsors & Collaborators

  • CroiValve Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296148 on ClinicalTrials.gov