No phaseRecruitingAge-related condition
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation
- Sponsor
- JenaValve Technology, Inc. (Industry)
- Enrollment
- 1,016 planned
- Conditions
- Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency
- Interventions
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System; SAVR
- Ages
- children, adults, older adults
- Registry
- NCT06608823
Full record on ClinicalTrials.gov
From the registry
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)
Primary outcomes
- All-Cause Mortality
- All stroke
- unplanned cardiac rehospitalization
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered