NCT06608823

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,016 (estimated)
• Sponsor: JenaValve Technology, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-06-01
• Completion: 2036-02-01
• First posted: 2024-09-23
• Last updated: 2026-04-13

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study