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NCT06368401

A First in Human Study for the Versa Device for Tricuspid Regurgitation

Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System
Versa Vascular, Inc·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Tricuspid Regurgitation
Drug/Device/Intervention
Versa Implant
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Versa Vascular, Inc
Location
Auckland, New Zealand
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Dec 31, 2025
Enrollment
10 participants
Primary outcome

Acute Procedural Success,Incidence of major adverse events (MAE)

Summary

This study is prospective, non-randomized, single-arm,first in human study to evaluate the
 safety and feasibility of the Versa Vascular System for intervention in adults with severe
 tricuspid regurgitation who are not surgical candidates.

ICD-10 classifications
Tricuspid stenosisTricuspid stenosis with insufficiencyNonrheumatic tricuspid (valve) stenosisTricuspid insufficiencyNonrheumatic tricuspid (valve) stenosis with insufficiency
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06368401
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06368401 through Pure Global AI's free database. This phase not specified trial is sponsored by Versa Vascular, Inc and is currently Not yet recruiting. The study focuses on Tricuspid Regurgitation. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.