RecruitingNot Applicable

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

United States1,016 participantsStarted 2025-06-18

Plain-language 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)

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Clinical indication for AVR for native valve predominant AR defined as:
✓. 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
✓. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion criteria

✕. 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
✕. Subject refuses a blood transfusion
✕. Subject is selected for aortic valve repair or aortic surgery
✕. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention
✕. Subject unable to undergo pre-procedure CT scan analysis for annular sizing

What they're measuring

All-Cause Mortality

Timeframe: 12 months

All stroke

Timeframe: 12 months

unplanned cardiac rehospitalization

Timeframe: 12 months

Trial details

NCT IDNCT06608823

SponsorJenaValve Technology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Duane Pinto, MD MPH

949-767-2110 pinto@jenavalve.com

View on ClinicalTrials.gov More Aortic Regurgitation trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Clinical indication for AVR for native valve predominant AR defined as:
✓. 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
✓. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion criteria

✕. 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
✕. Subject refuses a blood transfusion
✕. Subject is selected for aortic valve repair or aortic surgery
✕. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention
✕. Subject unable to undergo pre-procedure CT scan analysis for annular sizing