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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: Recruiting NA study of Tricuspid Regurgitation and Tricuspid Valve Disease, sponsored by VDyne.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2030-11-30 |
| Phase | NA |
What NCT05848284 shows while recruiting
NCT05848284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 534-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (94% lower).
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 lists 12 locations in 9 states (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.
Learn More About Clinical Trials
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 NCT05848284's enrollment target sits among peer trials
30 15th of 17 higher than 2 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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-
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-
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