JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
NCT07363473 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-05
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
- 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.
Sponsors & Collaborators
-
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
lead INDUSTRY
Principal Investigators
-
Richard Cheng, MD · University of California, Los Angeles
-
Andrew Morse, MD · Ascension St. Thomas
-
Ulrich Jorde, MD · Montefiore Health System
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-11-30
- Completion
- 2029-11-30
- FDA Device
- Yes
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