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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
J-Valve Transfemoral System
DeviceTreatment 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: J-Valve Transfemoral SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
Freedom from moderate or severe total aortic regurgitation
Time frame
30 days2
Primary Safety Endpoint
Freedom from all-cause mortality
Time frame
30 daysSecondary outcomes
1
Valve embolization
Valve embolization
Time frame
During index procedure2
Need for second bioprosthetic valve
Need for second bioprosthetic valve
Time frame
During index procedure3
Change in cardiovascular-specific health status
Change in cardiovascular-specific health status as measured by the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score
Time frame
30 days compared with baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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