New heart valve replacement could offer hope for severe leakage

NCT ID NCT06611579

Recruiting now Disease control Sponsor: inQB8 Medical Technologies, LLC Source: ClinicalTrials.gov ↗

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.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for TRICUSPID VALVE REGURGITATION are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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 VALVE REGURGITATION

Contacts and locations

Locations

AZ Sint-Jan Brugge AV
RECRUITING

Bruges, 8000, Belgium
Baylor Heart Hospital
RECRUITING

Plano, Texas, 75093, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Los Robles Hosptial and Medical Center
RECRUITING

Thousand Oaks, California, 91360, United States
North Shore University Hospital
RECRUITING

Manhasset, New York, 11030, United States
Penn Presbyterian Medical Center
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Piedmont Atlanta Hospital
RECRUITING

Atlanta, Georgia, 30309, United States
St. Michael's Hospital
RECRUITING

Toronto, Ontario, M5B1W8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.