The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Universität Bochum
Bad Oeynhausen, Germany
RECRUITINGCharité university
Berlin, Germany
RECRUITINGUniklinik Bonn
Bonn, Germany
Freedom from device or procedure-related adverse events
Freedom from device or procedure-related adverse events
Time frame: 30 days
Reduction in TR grade
Reduction in TR in comparison to baseline
Time frame: 30 days
Six minute walk test
Change in Six minute walk distance from Baseline
Time frame: 30 days, 6 months, 12 months, annual for five years
KCCQ
Change in health status from Baseline
Time frame: 30 days, 6 months, 12 months, annual for five years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Herzzentrum Uniklinik
Cologne, Germany
RECRUITINGUniversitäres Herz
Hamburg, Germany
RECRUITINGUniversity Heart Center Lübeck
Lübeck, Germany
RECRUITINGUniversitätsklinikum - Regensburg
Regensburg, Germany
RECRUITING