New heart valve replacement could offer hope for severe leakage

NCT ID NCT06611579

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called the inQB8 MonarQ system, which replaces the tricuspid valve using a thin tube (catheter) instead of open-heart surgery. It includes 50 people with severe tricuspid regurgitation, a condition where the valve leaks. The goal is to see if the device is safe and can reduce the leakage, improve heart function, and enhance quality of life.

What this could mean

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

Active substance

inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System (a device placed through a catheter to replace the tricuspid valve)

What this could lead to

If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation, potentially improving heart function and daily life.

What could go wrong

This is an early study with only 50 participants, so results may not apply to everyone. The procedure carries risks like any heart device implant, and long-term benefits are not yet proven.

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

  • AZ Sint-Jan Brugge AV

    RECRUITING

    Bruges, 8000, Belgium

    Contact

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

  • Baylor Heart Hospital

    RECRUITING

    Plano, Texas, 75093, United States

    Contact

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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

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

    Contact

  • Los Robles Hosptial and Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

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

    Contact

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

    Contact

    Contact

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

  • Penn Presbyterian Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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

    Contact

  • Piedmont Atlanta Hospital

    RECRUITING

    Atlanta, Georgia, 30309, United States

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

    Contact

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B1W8, Canada

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

    Contact