Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Replacement of the tricuspid valve using a transcatheter approach
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGLos Robles Hosptial and Medical Center
Thousand Oaks, California, United States
RECRUITINGPiedmont Atlanta Hospital
Atlanta, Georgia, United States
Absence of device or procedure related major adverse events
Time frame: 30 days
Change in TR grade from baseline
Time frame: 30 days
Device and procedure related complications
Rate of Device and procedure related complications
Time frame: 30 days and 12 months
NYHA functional classification
Change in NYHA functional class from baseline
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Six-minute-walk test
Change in distance from baseline
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Health status - KCCQ
Change in quality of life from baseline
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
TR grade
Change in TR Grade from baseline
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Hospitalization
Rate of all-cause hospitalization
Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
North Shore University Hospital
Manhasset, New York, United States
RECRUITINGPenn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
RECRUITINGBaylor Heart Hospital
Plano, Texas, United States
RECRUITING