ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

Recruiting now · Not applicable

Conditions studied: Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency

In brief

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)

Key facts

Study ID: NCT06608823
Run by: JenaValve Technology, Inc.
People needed: 1016
Starts: 2025-06-18
Expected to finish: 2036-02-01
Last updated by the study team: 2026-07-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected.
Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
Hostile chest or conditions or complications from a prior surgery that would preclude safe reoperation (i.e., mediastinitis, radiation damage, chest wall abnormalities, adhesion of aorta or internal mammary artery (IMA) to the sternum)
Need for emergency surgery or TAVR for any reason
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support
Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization
LVEF \&amp;lt;25% according to core laboratory measurement of resting echocardiogram at time of screening
Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory
Severe chronic liver disease (Child-Pugh C) or any active liver disease
Chronic Kidney Disease Stage 4 or 5 (\&amp;lt;30 cc/min/1.73 m2 or dialysis)
Severe Pulmonary Hypertension (pulmonary arterial systolic pressure
amp;amp;gt;2/3 systemic systolic pressure)
Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1
amp;amp;lt;50% predicted or need for chronic supplementary oxygen
Blood dyscrasia as defined: leukopenia (WBC \&amp;lt;3,000 Cells/μL), thrombocytopenia (platelet count \&amp;lt;50,000 Cells/μL), or anemia (hemoglobin \&amp;lt;9.0 g/dL) that is uncorrected prior to randomization
History of bleeding diathesis or coagulopathy that is not adequately treated

Where it is running

CPMC Sutter Health — Burlingame, California, United States (enrolling)
Scripps Health — La Jolla, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Los Robles Medical Center — Thousand Oaks, California, United States (enrolling)
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
BayCare Health — Clearwater, Florida, United States (enrolling)
HCA North Florida — Gainesville, Florida, United States (enrolling)
Emory University Hospital — Atlanta, Georgia, United States (enrolling)
Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
Heart Care Centers of IL / Hinsdale Hospital — Chicago, Illinois, United States (enrolling)
Ascension St. Vincent Heart Center — Carmel, Indiana, United States (enrolling)
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Henry Ford Health — Detroit, Michigan, United States (enrolling)
Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States (enrolling)
Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
Buffalo General Medical Center — Buffalo, New York, United States (enrolling)
Columbia University Medical Center — New York, New York, United States (enrolling)
The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
Ohio Health — Columbus, Ohio, United States (enrolling)
Oregon Health & Science University (OHSU) — Portland, Oregon, United States (enrolling)
Lankenau Institute for Medical Research — Philadelphia, Pennsylvania, United States (enrolling)
Houston Methodist Research Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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