MedTrace Logo

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

NCT06368401 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Versa Implant

The Versa Vascular Implant and Delivery System consists of a percutaneously delivered, permanent right-atrial implant and the delivery catheter that is used to first position the implant over the native valve orifice and to then place the implant.

Sponsors & Collaborators

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Versa Vascular, Inc

    lead INDUSTRY

Principal Investigators

  • Mark Webster, MD · Auckland City Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2024-12-30
Completion
2025-10-02

Countries

  • Chile
  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368401 on ClinicalTrials.gov