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NCT06608823 · ClinicalTrials.gov registry record · NA

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

A NA study of Aortic Valve Insufficiency and Aortic Regurgitation, sponsored by JenaValve Technology.

Recruiting
Registry status
NA
Development phase
1,016
Enrollment target
20
Study locations

NCT06608823 is a NA study of Aortic Valve Insufficiency and Aortic Regurgitation that is actively recruiting participants, run by JenaValve Technology. The registered enrollment target is 1,016 participants, below the 1,299-participant average among 11 other Aortic Valve Insufficiency trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06608823, a NA study of Aortic Valve Insufficiency and Aortic Regurgitation, is actively recruiting participants, sponsored by JenaValve Technology.

RECRUITING
Registry status
NA
Development phase
1,016 participants
Enrollment target
20
Study locations

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 Studied

Aortic Valve Insufficiency Aortic Regurgitation Aortic Insufficiency

Interventions

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

Study Locations (20)

California

  • CPMC Sutter Health - Burlingame
  • Scripps Health - La Jolla
  • Cedar-Sinai Medical Center - Los Angeles

Florida

  • BayCare Health - Clearwater
  • HCA North Florida - Gainesville

Georgia

  • Emory University Hospital - Atlanta
  • Piedmont Healthcare - Atlanta

Michigan

  • University of Michigan - Ann Arbor
  • Henry Ford Health - Detroit

Ohio

  • The Christ Hospital - Cincinnati
  • Ohio Health - Columbus

Texas

  • Houston Methodist Research Institute - Houston
  • Baylor Scott & White Health - Plano

Utah

  • Intermountain Health - Murray
  • Intermountain Healthcare - Murray

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 1,016 participants
Start Date 2025-06-18
Est. Completion 2036-02
Phase NA

Sponsor

JenaValve Technology

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06608823

The ClinicalTrials.gov registry entry for NCT06608823 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,016 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,299-participant average among 11 other Aortic Valve Insufficiency trials with a reported enrollment target (22% lower). The listed sponsor is JenaValve Technology, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Aortic Valve Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which SAVR is the first listed.

NCT06608823 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06608823 about?

NCT06608823 is a clinical study titled "ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™". 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)

What is the current status of trial NCT06608823?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,016 participants. The study started on 2025-06-18. Estimated completion is 2036-02.

What conditions does trial NCT06608823 study?

This clinical trial studies the following conditions: Aortic Valve Insufficiency, Aortic Regurgitation, Aortic Insufficiency.

What interventions are being tested in trial NCT06608823?

The interventions under investigation include: SAVR (DEVICE), Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System (DEVICE).

Who is sponsoring clinical trial NCT06608823?

This trial is sponsored by JenaValve Technology, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06608823 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.