New valve device offers hope for High-Risk heart patients

NCT ID NCT06568003

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called LuX-Valve Plus, which is a replacement heart valve delivered through a vein, for people with severe tricuspid regurgitation (a leaky heart valve). The 15 participants have symptoms and are not candidates for surgery. The goal is to see if the device can safely reduce the leak and improve symptoms.

What this could mean

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

Active substance

LuX-Valve Plus system (a replacement heart valve delivered through a vein)

What this could lead to

If it works, this could offer a less risky treatment option for people with severe tricuspid regurgitation who are too sick for open-heart surgery.

What could go wrong

This is a very small early study with only 15 people, so results may not apply to everyone. The procedure carries serious risks like bleeding, stroke, or need for a pacemaker.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States