Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)
JenaValve Technology, Inc.
Summary
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects \>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3: • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1 2. Patient with NYHA functional cl…
Interventions
- DeviceJenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System
Locations (15)
- Cedars-Sinai Medical CenterLos Angeles, California
- Sutter HealthSan Francisco, California
- Medstar Washington Hospital CenterWashington D.C., District of Columbia
- Emory UniversityAtlanta, Georgia
- PiedmontAtlanta, Georgia
- Advocate Christ Medical CenterOak Lawn, Illinois