Clinical Study of the inQB8 TTVR System
- Conditions
- Tricuspid Valve Regurgitation
- Interventions
- Device: Transcatheter Tricuspid Valve Replacement
- Registration Number
- NCT06611579
- Lead Sponsor
- inQB8 Medical Technologies, LLC
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Transcatheter Tricuspid Valve Replacement Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
- Primary Outcome Measures
Name Time Method Absence of device or procedure related major adverse events 30 days Change in TR grade from baseline 30 days
- Secondary Outcome Measures
Name Time Method Device and procedure related complications 30 days and 12 months Rate of Device and procedure related complications
NYHA functional classification 30 days, 6 months, 1 year, and through study completion, an average of 1 year Change in NYHA functional class from baseline
Six-minute-walk test 30 days, 6 months, 1 year, and through study completion, an average of 1 year Change in distance from baseline
Health status - KCCQ 30 days, 6 months, 1 year, and through study completion, an average of 1 year Change in quality of life from baseline
TR grade 30 days, 6 months, 1 year, and through study completion, an average of 1 year Change in TR Grade from baseline
Hospitalization 30 days, 6 months, 1 year, and through study completion, an average of 1 year Rate of all-cause hospitalization
Trial Locations
- Locations (5)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Los Robles Hosptial and Medical Center
🇺🇸Thousand Oaks, California, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Heart Hospital
🇺🇸Plano, Texas, United States