Medtronic Cardiovascular
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.
Inclusion Criteria: * 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. Exclusion Criteria: * Any tricuspid device currently in place. * Anatomic contraindications. * Need for emergent or urgent surgery. * Left ventricular ejection fraction \<25%.
Transcatheter Tricuspid Valve Replacement
Transcatheter Tricuspid Valve Replacement
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