RecruitingNot ApplicableNCT06611579
Clinical Study of the inQB8 TTVR System (The MonarQ Study)
A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
Sponsor
inQB8 Medical Technologies, LLC
Enrollment
50 participants
Start Date
Jun 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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
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Interventions
DEVICETranscatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve using a transcatheter approach
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06611579
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