JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJC Medical, Inc., an affiliate of Edwards Lifesciences LLC
About this trial
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).
Eligibility criteria
Qualifiers
Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction
Symptomatic according to New York Heart Association (NYHA) functional class II or higher
High risk for surgery as judged by a multi-disciplinary heart team
Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
Disqualifiers
Prior aortic valve replacement or repair
Aortic valve stenosis > moderate as assessed by core lab
Severe mitral valve or tricuspid valve regurgitation as assessed by core lab
Severe mitral valve or tricuspid valve stenosis as assessed by core lab
Trial design
Treatments tested in this trial
- J-Valve Transfemoral System
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov