New heart valve fix could spare High-Risk patients from major surgery

NCT ID NCT07172477

Recruiting now Disease control Sponsor: Tau Medical Australia Pty Ltd Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a new device called the Pivot Extend in 10 adults with severe tricuspid regurgitation (a leaky heart valve) who are too high-risk for surgery. The device is threaded through a vein in the leg to the heart, where it helps the valve flaps close tightly. The goal is to see if it is safe and can reduce the backward flow of blood, easing symptoms like shortness of breath and fatigue.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Pivot Extend device (a catheter-delivered implant to help the tricuspid valve close)
What this could lead to: If it works, this could offer a less risky option for people with severe tricuspid regurgitation who cannot have open-heart surgery.
What could go wrong: This is a very early feasibility study with only 10 participants, so results may not apply to everyone. The device could fail to reduce leakage or cause serious complications like stroke or heart attack.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TRICUSPID REGURGITATION

Contacts and locations

Locations

Macquarie University
RECRUITING

Macquarie Park, New South Wales, 2109, Australia

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