New valve device offers hope for High-Risk heart patients

NCT ID NCT06568003

Ongoing Disease control Sponsor: Jenscare Innovation Inc. Source: ClinicalTrials.gov ↗

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.

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 (TR)

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

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