NCT07363473

JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).

Conditions

• Aortic Valve Regurgitation
• Aortic Valve Disease Mixed
• Aortic Insufficiency

Interventions

Type	Name	Description
DEVICE	J-Valve Transfemoral System	Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-01
• Completion: 2029-11-01
• First posted: 2026-01-23
• Last updated: 2026-03-05

Regulatory

• FDA-regulated device study