ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJenaValve Technology, Inc.
About this trial
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 criteria
Qualifiers
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
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 local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR
The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve
Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Disqualifiers
Confirmed moderate (2+) or less AR severity by core laboratory evaluation
Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions
Subject is high-risk for SAVR as determined by the local heart team
Subject refuses SAVR as a treatment option
Trial design
Treatments tested in this trial
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System
- SAVR
Treatment groups
1,016 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov