Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
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Symptomatic tricuspid regurgitation (TR) despite medical therapy
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TR graded as severe or greater
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Appropriate for transcatheter tricuspid valve replacement per the local heart team
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Tricuspid valve anatomic contraindications
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Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
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Hemodynamic instability
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Refractory heart failure requiring advanced intervention
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Currently participating in another investigational study in which the patient has not reached a primary endpoint
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Tricuspid Valve Insufficiency
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