A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
inQB8 Medical Technologies, LLC
Summary
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 t…
Interventions
- DeviceTranscatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve using a transcatheter approach
Locations (6)
- Cedars-Sinai Medical CenterLos Angeles, California
- Los Robles Hosptial and Medical CenterThousand Oaks, California
- Piedmont Atlanta HospitalAtlanta, Georgia
- North Shore University HospitalManhasset, New York
- Penn Presbyterian Medical CenterPhiladelphia, Pennsylvania
- Baylor Heart HospitalPlano, Texas