Tiny trial tests catheter fix for leaky heart valves

NCT ID NCT07188233

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early study is testing a new device called CathHELIX that aims to repair a leaky mitral valve using a thin tube (catheter) instead of open-heart surgery. The trial will enroll just 5 people with moderate to severe mitral regurgitation who have symptoms like shortness of breath. The main goal is to see if the device can be safely placed and work as intended.

What this could mean

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

Active substance

CathHELIX Transcatheter Mitral Annuloplasty System (a device)

What this could lead to

If successful, this could offer a less invasive repair option for people with leaky mitral valves, potentially reducing symptoms and improving heart function.

What could go wrong

This is a very early feasibility study with only 5 people. The device may not work as intended, and risks include complications from the procedure or the need for emergency surgery.

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.

mitral valve insufficiency

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Tbilisi Heart and Vascular Clinic

    RECRUITING

    Tbilisi, Georgia, Georgia

    Contact

  • Vilnius University Hospital, Santaros Klinikos, Public Institution

    RECRUITING

    Vilnius, Lithuania, Lithuania

    Contact

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