This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,186
Transcatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement
Rate of Major Adverse Events (MAE)
Time frame: 30-days post-procedure
Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention
Time frame: 1-year post-procedure
Tricuspid regurgitation (TR) grade reduction
Total number of patients with at least one grade TR reduction
Time frame: 6 months post-procedure
Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
KCCQ overall summary score is a patient-reported measure of health status. Scores range from 0 to 100 where higher scores reflect better quality of life
Time frame: 6 months post-procedure
All-cause mortality
Time frame: 12 months post-procedure
Heart failure hospitalization
Time frame: 12 months post-procedure
New onset conduction disturbance (NOCD)
Time frame: 30 days post-procedure
Total procedure time
Time frame: Procedure
Right ventricle (RV) dysfunction
Time frame: 12 months post-procedure
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