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ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

This study, called ARTIST, is looking at two ways to treat severe aortic regurgitation (AR), a condition where the heart's aortic valve doesn't close properly, causing blood to leak backward. Researchers want to see if the Trilogy Transcatheter Heart Valve (THV) System, which is a less invasive procedure, works as well as traditional surgical aortic valve replacement (SAVR). You might be able to join if you have a clinical need for aortic valve replacement due to moderate to severe or severe AR. The study will compare how well these two treatments prevent death, stroke, and unplanned hospital stays related to your heart condition within 12 months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 1016 participants. It compares two different treatment approaches for aortic regurgitation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to assess outcomes like all-cause mortality, stroke, and unplanned cardiac rehospitalization.

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NCT06608823

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

Recruiting
NAAll AgesInterventionalTreatment
JenaValve Technology, Inc.
~1,016 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV SystemSAVR

At a glance

Recruiting sites
29 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All-Cause Mortality
Measured over 12 months
+2 more outcomes measured

Conditions

Aortic Regurgitation
Aortic Valve Insufficiency
Aortic Insufficiency

Explore related trials

Aortic Valve Insufficiency

Where it's being run

29 sites across 19 states
California4
Ohio3
Florida2
Georgia2
Michigan2
New York2
Texas2
District of Columbia1

Study leadership

  • Vinod H Thourani, MD · PRINCIPAL_INVESTIGATOR · Piedmont Heart Institute
  • Torsten P Vahl, MD · PRINCIPAL_INVESTIGATOR · Columbia University
  • Raj Makkar, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
  • Hendrik Treede, MD · PRINCIPAL_INVESTIGATOR · Department of Cardiovascular Surgery Johannes-Gutenberg University

Who to contact

Duane Pinto, MD MPH
[email protected]
949-767-2110
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

amp;amp;gt;2/3 systemic systolic pressure) 21. Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1
amp;amp;lt;50% predicted or need for chronic supplementary oxygen 22. Blood dyscrasia as defined: leukopenia (WBC \<3,000 Cells/μL), thrombocytopenia (platelet count \<50,000 Cells/μL), or anemia (hemoglobin \<9.0 g/dL) that is uncorrected prior to randomization 23. History of bleeding diathesis or coagulopathy that is not adequately treated 24. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy 25. Any condition considered a contraindication to mechanical circulatory support 26. Uncontrolled atrial fibrillation (i.e., resting heart rate \>120 bpm) 27. Evidence of an acute myocardial infarction ≤30 days before the index AVR 28. Any percutaneous coronary or peripheral interventional procedure performed ≤30 days prior to AVR (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe) 29. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization 30. Prior stroke with residual modified Rankin Score ≥2 31. Stroke or transient ischemic attack (TIA) within 6 months of randomization 32. Body mass index (BMI) \<20 or \>50 kg/m2 33. Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries) 34. Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 35. Other medical, social, or psychological conditions that in the opinion of the investigator preclude the subject from appropriate consent or adherence to the protocol required follow-up exams 36. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements

What this trial measures

  • All-Cause Mortality12 months

    all-cause mortality at 12 months

  • All stroke12 months

    Number of patients that had stroke

  • unplanned cardiac rehospitalization12 months

    Number of patients who had unplanned cardiac rehospitalization