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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
KP IRB No. |
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1714747 |
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| Study Type |
Phase |
| Clinical Trial |
n/a |
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| Study Population Description |
| (Adult, Older Adult) Male and Female with Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure |
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| Purpose |
| Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system |
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| Detailed Description |
| 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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| Gender |
Age Limit |
| Male & Female |
18 years & older |
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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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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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