A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation
JenaValve Technology, Inc.
Summary
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Clinical indication for AVR for native valve predominant AR defined as: 1. Class I or II indication for AVR according to ACC/AHA or ESC/EACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR 2. AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage\* from AR with unanimous agreement from the loca…
Interventions
- DeviceTranscatheter Aortic Valve Replacement (TAVR) using Trilogy THV System
Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device
- DeviceSAVR
SAVR using commercially available surgical prosthetic valves.
Locations (21)
- CPMC Sutter HealthBurlingame, California
- Scripps HealthLa Jolla, California
- Cedar-Sinai Medical CenterLos Angeles, California
- BayCare HealthClearwater, Florida
- HCA North FloridaGainesville, Florida
- Emory University HospitalAtlanta, Georgia