Actively Recruiting
Clinical Study of the inQB8 TTVR System
Led by inQB8 Medical Technologies, LLC · Updated on 2025-11-04
50
Participants Needed
6
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
CONDITIONS
Official Title
Clinical Study of the inQB8 TTVR System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Los Robles Hosptial and Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
3
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
5
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Baylor Heart Hospital
Plano, Texas, United States, 75093
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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