ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

NCT06608823 | Recruiting DMC FDA Device

• 1 other identifier: JVT24001
• Study Type: interventional
• Target: 1,016
• Locations: 1 country
• Sites: 21

Brief 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)

Conditions

Aortic Valve Insufficiency; Aortic Insufficiency; Aortic Regurgitation

Outcome Measures

Primary Outcomes (3)

• All-Cause Mortality

  all-cause mortality at 12 months

  12 months

• All stroke

  Number of patients that had stroke

  12 months

• unplanned cardiac rehospitalization

  Number of patients who had unplanned cardiac rehospitalization

  12 months

Secondary Outcomes (20)

• Length of index hospitalization

  pre-intervention/procedure surgery

• Echocardiographic effective orifice area

  30 days

• Moderate or greater patient prosthesis mismatch as measured by echo

  30 days or immediately after the intervention/procedure

• Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)

  30 days

• Atrial fibrillation

  30 days

Study Arms (2)

Transcatheter Aortic Valve Replacement (TAVR)

EXPERIMENTAL

Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System

Device: Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System

SAVR

OTHER

SAVR using commercially available surgical prosthetic valve

Device: SAVR

Interventions

Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System DEVICE

Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device

Transcatheter Aortic Valve Replacement (TAVR)

SAVR DEVICE

SAVR using commercially available surgical prosthetic valves.

SAVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• JenaValve Technology, Inc.: lead

Study Sites (21)

CPMC Sutter Health

Burlingame, California, 94010, United States

RECRUITING

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

BayCare Health

Clearwater, Florida, 33756, United States

RECRUITING

HCA North Florida

Gainesville, Florida, 32605, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30369, United States

RECRUITING

Heart Care Centers of IL / Hinsdale Hospital

Chicago, Illinois, 60521, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02420, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Minneapolis Heart Institute Founcation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Cumc/Nyph

New York, New York, 10032, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Ohio Health

Columbus, Ohio, 43214, United States

RECRUITING

Lankenau Institute for Medical Research

Philadelphia, Pennsylvania, 19096, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White Health

Plano, Texas, 75074, United States

RECRUITING

Intermountain Health

Murray, Utah, 84111, United States

RECRUITING

Intermountain Healthcare

Murray, Utah, 84119, United States

RECRUITING

Sentara Norfolk

Norfolk, Virginia, 23507, United States

RECRUITING

Related Links

• Chronic Severe Aortic Regurgitation: Should We Lower Operating Thresholds?
• Global longitudinal strain in chronic asymptomatic aortic regurgitation: systematic review
• 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines

MeSH Terms

Conditions

Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Vinod H Thourani, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Torsten P Vahl, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Raj Makkar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Hendrik Treede, MD

  Department of Cardiovascular Surgery Johannes-Gutenberg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duane Pinto, MD MPH

CONTACT

949-767-2110; pinto@jenavalve.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2036
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)