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Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation

NCT07172477 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-09

No results posted yet for this study

Summary

Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions.

The goal of this clinical investigation is

* To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention
* To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Pivot Extend

The investigational "Pivot Extend" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Extend device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve.

Sponsors & Collaborators

  • Tau-MEDICAL Co., Ltd.

    collaborator INDUSTRY

  • Tau Medical Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • June-Hong Kim, PhD · Tau-MEDICAL Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-04-30
Completion
2027-03-31

Countries

  • Australia

Study Locations

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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 NCT07172477 on ClinicalTrials.gov