ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ (ARTIST)

May 18, 2026 updated by: JenaValve Technology, Inc.

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1016

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Burlingame, California, United States, 94010
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Raj Makkar, MD
        • Contact:
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Medical Center
        • Principal Investigator:
          • Saibal Kar, MD
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • BayCare Health
        • Principal Investigator:
          • Joshua Rovin, MD
        • Contact:
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • HCA North Florida
        • Principal Investigator:
          • Charles Klodell, MD
        • Contact:
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • Adam Greenbaum, MD
        • Contact:
      • Atlanta, Georgia, United States, 30369
        • Recruiting
        • Piedmont HealthCare
        • Principal Investigator:
          • Pradeep Yadav, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60521
        • Recruiting
        • Heart Care Centers of IL / Hinsdale Hospital
        • Principal Investigator:
          • Ravi Ramana, DO
        • Contact:
    • Indiana
      • Carmel, Indiana, United States, 46290
    • Massachusetts
      • Boston, Massachusetts, United States, 02420
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Marie-France Poulin, MD
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Stanley Chetcuti, MD
        • Contact:
          • Allison Schley
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tiberio Frisoli
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Principal Investigator:
          • Mario Goessl, MD
        • Contact:
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Medical Center
        • Principal Investigator:
          • Vijay Iyer, MD
        • Contact:
        • Contact:
      • New York, New York, United States, 10032
    • Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Institute for Medical Research
        • Principal Investigator:
          • Basel Ramlawi, MD
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75074
    • Utah
      • Murray, Utah, United States, 84111
        • Recruiting
        • Intermountain Health
        • Principal Investigator:
          • Brian Whisenant, MD
        • Contact:
      • Murray, Utah, United States, 84119
        • Recruiting
        • Intermountain Healthcare
        • Principal Investigator:
          • Brian Whisenant, MD
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk
        • Principal Investigator:
          • Matthew Summers, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical indication for AVR for native valve predominant AR defined as:

    1. 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
    2. 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
  2. The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve
  3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
  4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusion Criteria:

  1. Confirmed moderate (2+) or less AR severity by core laboratory evaluation
  2. Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions
  3. Subject is high-risk for SAVR as determined by the local heart team
  4. Subject refuses SAVR as a treatment option
  5. Subject refuses a blood transfusion
  6. Subject is selected for aortic valve repair or aortic surgery
  7. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention
  8. Subject unable to undergo pre-procedure CT scan analysis for annular sizing
  9. Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected.
  10. 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
  11. 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)
  12. Need for emergency surgery or TAVR for any reason
  13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support
  14. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
  15. Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization
  16. LVEF <25% according to core laboratory measurement of resting echocardiogram at time of screening
  17. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory
  18. Severe chronic liver disease (Child-Pugh C) or any active liver disease
  19. Chronic Kidney Disease Stage 4 or 5 (<30 cc/min/1.73 m2 or dialysis)

  20. Severe Pulmonary Hypertension (pulmonary arterial systolic pressure

    • 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

  37. Anatomical exclusion criteria (ANY of the following):

    1. Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory
    2. Native aortic annulus perimeter <66 mm or >90 mm per the core laboratory reading of baseline cardiac CT imaging
    3. Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB)
    4. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation) that would preclude safe passage of the delivery system or cannulation and aortotomy for SAVR
    5. According to the CRB, a combination of aortic root angulation (angle between the plane of the aortic valve annulus and horizontal plane/vertebrae), sinus size, and straight length of the aorta that will not allow safe device delivery and THV deployment
    6. Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation
  38. According to core laboratory evaluation, severe aortic stenosis
  39. Uncorrected hypertrophic obstructive cardiomyopathy
  40. Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation
  41. Left ventricular thrombus
  42. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure

  43. Complex coronary artery disease:

    1. Unprotected left main coronary artery disease ≥50%
    2. Syntax score >32 (in the absence of prior revascularization)
    3. Heart Team determines that optimal revascularization cannot be adequately performed with EITHER CABG at the time of SAVR OR PCI at least 30 days prior to THV implant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System
Device: Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System
Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device
Other: SAVR
SAVR using commercially available surgical prosthetic valve
Device: SAVR
SAVR using commercially available surgical prosthetic valves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 12 months
all-cause mortality at 12 months
12 months
All stroke
Time Frame: 12 months
Number of patients that had stroke
12 months
unplanned cardiac rehospitalization
Time Frame: 12 months
Number of patients who had unplanned cardiac rehospitalization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of index hospitalization
Time Frame: pre-intervention/procedure surgery
comparing TAVR length of index hospitalization with SAVR
pre-intervention/procedure surgery
Echocardiographic effective orifice area
Time Frame: 30 days
comparing TAVR Echocardiographic effective orifice area with SAVR
30 days
Moderate or greater patient prosthesis mismatch as measured by echo
Time Frame: 30 days or immediately after the intervention/procedure
comparing TAVR moderate or greater patient prosthesis mismatched with SAVR
30 days or immediately after the intervention/procedure
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)
Time Frame: 30 days
comparing change in KCCQ-OS in TAVR with SAVR. the minimum and maximum values vary based on the questionnaire. Higher scores mean better outcome.
30 days
Atrial fibrillation
Time Frame: 30 days
comparing the onset atrial fibrillation in TAVR with SAVR
30 days
Cardiovascular rehospitalization
Time Frame: 30 days
comparing the number of cardiovascular rehospitalizations in TAVR with SAVR
30 days
Composite primary endpoints
Time Frame: 30 days
comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR
30 days
Composite primary endpoints
Time Frame: 1 year
comparing the superiority of the composite primary endpoint and its components in TAVR with SAVR
1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 30 days
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
30 days
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 6 months
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
6 months
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 1 year
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 2 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
2 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 3 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
3 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 4 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
4 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 5 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
5 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 6 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
6 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 7 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
7 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 8 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
8 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 9 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
9 years
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 10 years
Freedom of Major Adverse Cardiovascular and Cerebrovascular Events
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JenaValve Technology, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

February 1, 2036

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JVT24001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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