Clinical Study of the inQB8 TTVR System (The MonarQ Study)
Recruiting now · Not applicable
Conditions studied: Tricuspid Valve Regurgitation
In brief
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Key facts
- Study ID
- NCT06611579
- Run by
- inQB8 Medical Technologies, LLC
- People needed
- 50
- Starts
- 2025-06-01
- Expected to finish
- 2030-10-31
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- Los Robles Hosptial and Medical Center — Thousand Oaks, California, United States (enrolling)
- Piedmont Atlanta Hospital — Atlanta, Georgia, United States (enrolling)
- North Shore University Hospital — Manhasset, New York, United States (enrolling)
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
- Baylor Heart Hospital — Plano, Texas, United States (enrolling)
- AZ Sint-Jan Brugge AV — Bruges, Belgium (enrolling)
- St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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