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

inQB8 Medical Technologies, LLC · NCT06611579

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
6
Study start
June 1, 2025
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Being studied: Transcatheter Tricuspid Valve Replacement

Conditions: Tricuspid Valve Regurgitation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

  • Cedars-Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: Mitch Gheorghiu · 310-423-6152 · Mitch.Gheorghiu@cshs.org

  • Los Robles Hosptial and Medical Center

    Thousand Oaks, CA 91360

    Site contact: Mane Arabyan · 805-796-3746 · mane.arabyan@hcahealthcare.com

  • Piedmont Atlanta Hospital

    Atlanta, GA 30309

    Site contact: Caryn Bernstein · 404-605-5688 · Caryn.Bernstein@piedmont.org

  • North Shore University Hospital

    Manhasset, NY 11030

    Site contact: Kristine McGowan · 516-881-7035 · KMcGowan@northwell.edu

  • Penn Presbyterian Medical Center

    Philadelphia, PA 19104

    Site contact: Marisa Konig · 215-662-8456 · Marisa.Konig@pennmedicine.upenn.edu

  • Baylor Heart Hospital

    Plano, TX 75093

    Site contact: Saba Ilyas · 469-814-4853 · Saba.Ilyas@bswhealth.org

Clinical Study of the inQB8 TTVR System (The MonarQ Study) (NCT06611579) | Bored Studies