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EFS of the DUO System for Tricuspid Regurgitation

NCT05913908 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-13

No results posted yet for this study

Summary

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Conditions

  • Tricuspid Regurgitation
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Disease
  • Heart Valve Diseases

Interventions

DEVICE

DUO Transcatheter Tricuspid Coaptation Valve System

Reduction of tricuspid regurgitation 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
2024-08-13
Primary Completion
2027-12-31
Completion
2029-10-31
FDA Device
Yes

Countries

  • United States
  • 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 NCT05913908 on ClinicalTrials.gov