Status:
RECRUITING
Clinical Study of the inQB8 TTVR System
Lead Sponsor:
inQB8 Medical Technologies, LLC
Conditions:
Tricuspid Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Detailed Description
The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06611579
Start Date
June 1 2025
End Date
October 31 2029
Last Update
November 4 2025
Active Locations (6)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Los Robles Hosptial and Medical Center
Thousand Oaks, California, United States, 91360
3
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
4
North Shore University Hospital
Manhasset, New York, United States, 11030