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Clinical Trials in the USA / NCT06611579
Recruiting Not applicable

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

NCT06611579 · tracked via the Priya Life Science USA tracker
Sponsor
inQB8 Medical Technologies, LLC
Phase
Not applicable
Started
2025-06-01
Last updated
2026-05-18

Condition(s) studied

Tricuspid Valve Regurgitation

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve using a transcatheter approach

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Absence of device or procedure related major adverse events — 30 days
  • Change in TR grade from baseline — 30 days

Trial sites (8)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California Recruiting
Los Robles Hosptial and Medical Center Thousand Oaks California Recruiting
Piedmont Atlanta Hospital Atlanta Georgia Recruiting
North Shore University Hospital Manhasset New York Recruiting
Penn Presbyterian Medical Center Philadelphia Pennsylvania Recruiting
Baylor Heart Hospital Plano Texas Recruiting
AZ Sint-Jan Brugge AV Bruges Belgium Recruiting
St. Michael's Hospital Toronto Ontario Recruiting

Other trials for the same condition

Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System Recruiting
TRISCEND II Pivotal Trial Active, not recruiting
The TRICURE EFS Study Recruiting
2019-06 TRISCEND Study Active, not recruiting
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06611579 on ClinicalTrials.gov ↗ ← All trials in the USA