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Clinical Study of the inQB8 TTVR System (The MonarQ Study)
Recruiting
A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
What is being tested
- Transcatheter Tricuspid Valve Replacement (device)
Sponsor: inQB8 Medical Technologies, LLC · Participants: 50 · Started: Jun 1, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06611579
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.