Actively Recruiting
A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
Led by inQB8 Medical Technologies, LLC · Updated on 2026-05-18
50
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System in adults with tricuspid valve regurgitation. This multi-center, prospective, single-arm study focuses on participants who have severe or greater symptomatic tricuspid regurgitation and are hemodynamically stable, with adequately treated heart failure according to medical standards. Participants will receive treatment with the inQB8 MonarQ Tricuspid Valve Replacement System, which replaces the tricuspid valve using a transcatheter approach. The study does not include a comparison group and involves only the investigational device intervention. The treatment is delivered through a minimally invasive procedure designed to address the valve condition. During the study, participants will be monitored for major adverse events related to the device or procedure within 30 days, and changes in tricuspid regurgitation grade from baseline will be assessed at 30 days. Secondary measures include device and procedure-related complications, heart function classification, walking ability, health status, repeat assessments of valve regurgitation, and hospitalization rates, which will be evaluated at multiple time points up to about one year on average. Safety and performance data will be collected throughout the study period.
CONDITIONS
Brief Title
Clinical Study of the inQB8 TTVR System (The MonarQ Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Anatomically suitable for the MonarQ TTVR System
- Symptomatic, tricuspid regurgitation that is severe or greater
- Adequately treated for heart failure based upon medical standards
- Hemodynamically stable
- Age 18 years or older
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)
- Any planned percutaneous cardiac procedure within the next 90 days
- Refractory heart failure requiring or having required advanced intervention
- Any condition making it unlikely the patient will 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo replacement of the tricuspid valve using the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety, device performance, and functional outcomes after the valve replacement procedure.
Visits at 30 days, 6 months, and 1 year post-procedure
Trial Site Locations
Total: 8 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
7
AZ Sint-Jan Brugge AV
Bruges, Belgium, 8000
Actively Recruiting
8
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
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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