NCT06611579 Clinical Study of the inQB8 TTVR System (The MonarQ Study)
| NCT ID | NCT06611579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | inQB8 Medical Technologies, LLC |
| Condition | Tricuspid Valve Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-06-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
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
Frequently Asked Questions
Who can join the NCT06611579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Valve Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06611579 currently recruiting?
Yes, NCT06611579 is actively recruiting participants. Visit ClinicalTrials.gov or contact inQB8 Medical Technologies, LLC to inquire about joining.
Where is the NCT06611579 trial being conducted?
This trial is being conducted at Los Angeles, United States, Thousand Oaks, United States, Atlanta, United States, Manhasset, United States and 4 additional locations.
Who is sponsoring the NCT06611579 clinical trial?
NCT06611579 is sponsored by inQB8 Medical Technologies, LLC. The trial plans to enroll 50 participants.