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.
Age ≥18 years at the time of consent.
Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).
Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.
Any tricuspid device currently in place.
Anatomic contraindications.
Need for emergent or urgent surgery.
Left ventricular ejection fraction <25%.
Parallel
Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
DeviceTranscatheter Tricuspid Valve Replacement
Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
DeviceTranscatheter Tricuspid Valve Replacement
Rate of Major Adverse Events (MAE)
Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention
Tricuspid regurgitation (TR) grade reduction
Total number of patients with at least one grade TR reduction
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
All-cause mortality
Heart failure hospitalization
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