RecruitingNot ApplicableNCT06608823

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

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

Sponsor

JenaValve Technology, Inc.

Enrollment

1,016 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Insufficiency Aortic Insufficiency aortic regurgitation

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)

Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SAVR and a medical device called Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System for people with aortic insufficiency, aortic valve insufficiency, and other related conditions. The study is currently recruiting participants at 27 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscatheter Aortic Valve Replacement (TAVR) using Trilogy THV System

Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device

DEVICESAVR

SAVR using commercially available surgical prosthetic valves.

Locations(34)

CPMC Sutter Health

Burlingame, California, United States

Scripps Health

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Los Robles Medical Center

Thousand Oaks, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

BayCare Health

Clearwater, Florida, United States

HCA North Florida

Gainesville, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Heart Care Centers of IL / Hinsdale Hospital

Chicago, Illinois, United States

Ascension St. Vincent Heart Center

Carmel, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Buffalo General Medical Center

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Health

Columbus, Ohio, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Lankenau Institute for Medical Research

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Houston Methodist Research Institute

Houston, Texas, United States

Baylor Scott & White Health

Plano, Texas, United States

Intermountain Health

Murray, Utah, United States

Sentara Norfolk

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06608823

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