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A First in Human Study for the Versa Device for Tricuspid Regurgitation - Trial NCT06368401

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT06368401
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A First in Human Study for the Versa Device for Tricuspid Regurgitation
Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System

Study Focus

Tricuspid Regurgitation

Versa Implant

Interventional

device

Sponsor & Location

Versa Vascular, Inc

Auckland, New Zealand

Timeline & Enrollment

N/A

Jun 01, 2024

Dec 31, 2025

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 stenosis
Tricuspid stenosis with insufficiency
Nonrheumatic tricuspid (valve) stenosis
Tricuspid insufficiency
Nonrheumatic tricuspid (valve) stenosis with insufficiency

Data Source

ClinicalTrials.gov

NCT06368401

Device Trial