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NCT05913908 · ClinicalTrials.gov registry record · NA

EFS of the DUO System for Tricuspid Regurgitation

A NA study of Tricuspid Regurgitation and Heart Valve Diseases, sponsored by CroiValve Limited.

Recruiting
Registry status
NA
Development phase
15
Enrollment target
16
Study locations

NCT05913908: Recruiting NA study of Tricuspid Regurgitation and Heart Valve Diseases, sponsored by CroiValve Limited.

NCT05913908 is a NA study of Tricuspid Regurgitation and Heart Valve Diseases that is actively recruiting participants, run by CroiValve Limited. The registered enrollment target is 15 participants, below the 535-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (97% lower). The trial reports 16 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05913908, a NA study of Tricuspid Regurgitation and Heart Valve Diseases, is actively recruiting participants, sponsored by CroiValve Limited.

RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
16
Study locations

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).

Primary Outcome

* Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism

Interventions

  • DEVICE DUO Transcatheter Tricuspid Coaptation Valve System

Study Locations (16)

New York

  • Columbia University Medical Center/NYPH - New York
  • Montefiore Medical Center - The Bronx

Arizona

  • Dignity Health St. Joseph's Hospital & Medical Center - Phoenix

California

  • Los Robles Hospital & Medical Center - Thousand Oaks

Georgia

  • Piedmont Heart Institute - Atlanta

Illinois

  • Northwestern University - Chicago

Kansas

  • Ascension Via Christi Research - Wichita

Minnesota

  • Allina Health Minneapolis Heart Institute Foundation - Minneapolis

Ohio

  • OhioHealth Research Institute - Columbus

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-08-13
Est. Completion 2029-10
Phase NA
CroiValve Limited

1 total trials

What NCT05913908 shows while recruiting

NCT05913908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 535-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (97% lower).

The record links to 4 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which DUO Transcatheter Tricuspid Coaptation Valve System is the first listed.

NCT05913908 lists 16 locations in 15 states (New York, Arizona, California).

Frequently Asked Questions

What is clinical trial NCT05913908 about?

NCT05913908 is a clinical study titled "EFS of the DUO System for Tricuspid Regurgitation". 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).

What is the current status of trial NCT05913908?

This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-08-13. Estimated completion is 2029-10.

What conditions does trial NCT05913908 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Disease, Tricuspid Valve Insufficiency.

What interventions are being tested in trial NCT05913908?

The interventions under investigation include: DUO Transcatheter Tricuspid Coaptation Valve System (DEVICE).

Who is sponsoring clinical trial NCT05913908?

This trial is sponsored by CroiValve Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05913908 being conducted?

This trial has 16 study locations across Arizona, California, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Tricuspid Regurgitation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05913908's enrollment target sits among peer trials

15 17th of 17 the lowest of 17 other Tricuspid Regurgitation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Tricuspid Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05913908, the US trial registry maintained by the National Library of Medicine. NCT05913908 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.