MedTrace Logo

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

NCT06608823 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1016

Last updated 2026-05-19

No results posted yet for this study

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 Regurgitation
  • Aortic Valve Insufficiency
  • Aortic Insufficiency

Interventions

DEVICE

Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System

Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device

DEVICE

SAVR

SAVR using commercially available surgical prosthetic valves.

Sponsors & Collaborators

  • JenaValve Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Vinod H Thourani, MD · Piedmont Heart Institute

  • Torsten P Vahl, MD · Columbia University

  • Raj Makkar, MD · Cedars-Sinai Medical Center

  • Hendrik Treede, MD · Department of Cardiovascular Surgery Johannes-Gutenberg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2026-06-30
Completion
2036-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06608823 on ClinicalTrials.gov