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The MonarQ Study for Tricuspid Valve Regurgitation

This study is testing a new device called the inQB8 TTVR System to treat Tricuspid Valve Regurgitation (TR), a condition where the heart's tricuspid valve doesn't close properly, causing blood to leak backward. The study aims to see how safe and effective this device is when used to replace the tricuspid valve through a minimally invasive procedure. You might be able to join if you are 18 or older, have severe TR with symptoms, and your heart failure is well-managed. The study will look at whether there are any major problems related to the device or procedure within 30 days, and if your TR improves. The current status of this study is unclear, and it plans to enroll about 50 participants.

Study design
This is a single-arm study, meaning all participants will receive the inQB8 TTVR System. It plans to enroll about 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess major adverse events and changes in TR grade at 30 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06611579

Clinical Study of the inQB8 TTVR System (The MonarQ Study)

Recruiting
NAAges 18+InterventionalTreatment
inQB8 Medical Technologies, LLC
~50 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Transcatheter Tricuspid Valve Replacement

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absence of device or procedure related major adverse events
Measured over 30 days
+1 more outcome measured

Conditions

Tricuspid Valve Regurgitation

Explore related trials

Tricuspid Valve Insufficiency

NCT06611579

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AZ Sint-Jan Brugge AV

    Bruges, Belgiumstudy coordinator listed

    Recruiting

  • Baylor Heart Hospital

    Plano, Texasstudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Los Robles Hosptial and Medical Center

    Thousand Oaks, Californiastudy coordinator listed

    Recruiting

  • North Shore University Hospital

    Manhasset, New Yorkstudy coordinator listed

    Recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Piedmont Atlanta Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, Canadastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Mitch Gheorghiu
[email protected]
310-423-6152
Email the study team

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Eligibility criteria

Inclusion

Anatomically suitable for the MonarQ TTVR System
Symptomatic, tricuspid regurgitation (TR) that is severe or greater
Adequately treated for heart failure based upon medical standards
Hemodynamically stable

Exclusion

Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
Refractory Heart Failure (HF) that requires or required advanced intervention
Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.
Currently participating in another investigational biologic, drug or device study

What this trial measures

  • Absence of device or procedure related major adverse events30 days
  • Change in TR grade from baseline30 days