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NCT05848284 · ClinicalTrials.gov registry record · NA

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

A NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, sponsored by VDyne.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
12
Study locations

NCT05848284 is a NA study of Tricuspid Regurgitation and Tricuspid Valve Disease that is actively recruiting participants, run by VDyne. The registered enrollment target is 30 participants, below the 534-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (94% lower). The trial reports 12 study locations across 9 states.

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The verdict

NCT05848284, a NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, is actively recruiting participants, sponsored by VDyne.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
12
Study locations

Study Summary

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

Conditions Studied

Tricuspid Regurgitation Tricuspid Valve Disease Tricuspid Valvular Disorders

Interventions

  • DEVICE VDyne Transcatheter Tricuspid Valve Replacement System

Study Locations (12)

California

  • Cedars-Sinai Medical Center - Los Angeles
  • Los Robles Hospital and Medical Center - Thousand Oaks

Minnesota

  • Minneapolis Heart Institute Foundation - Minneapolis
  • Mayo Clinic - Rochester - Rochester

New York

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

Michigan

  • Henry Ford Hospital - Detriot

Ohio

  • The Christ Hospital - Cincinnati

Oregon

  • Oregon Health and Science Unversity - Portland

South Carolina

  • Medical University of South Carolina - Charleston

Tennessee

  • Ascension St. Thomas - Nashville

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-04-01
Est. Completion 2030-11-30
Phase NA

Sponsor

VDyne

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05848284

The ClinicalTrials.gov registry entry for NCT05848284 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 534-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (94% lower). The listed sponsor is VDyne, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which VDyne Transcatheter Tricuspid Valve Replacement System is the first listed.

NCT05848284 reports 12 study locations spanning 9 distinct geographic areas - top geographies include California, Minnesota, New York.

Frequently Asked Questions

What is clinical trial NCT05848284 about?

NCT05848284 is a clinical study titled "Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)". The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

What is the current status of trial NCT05848284?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-04-01. Estimated completion is 2030-11-30.

What conditions does trial NCT05848284 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders.

What interventions are being tested in trial NCT05848284?

The interventions under investigation include: VDyne Transcatheter Tricuspid Valve Replacement System (DEVICE).

Who is sponsoring clinical trial NCT05848284?

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

Where is trial NCT05848284 being conducted?

This trial has 12 study locations across California, Michigan, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.