Not Yet RecruitingNot Applicable

JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

50 participantsStarted 2026-04

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Written informed consent and agreement to comply with all required follow-up visits at investigational site
✕. 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
✕. Active infection requiring current antibiotic therapy, including infective endocarditis
✕. Cardiac imaging evidence of cardiac mass, thrombus or vegetation
✕. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy

What they're measuring

Primary Effectiveness Endpoint

Timeframe: 30 days

Primary Safety Endpoint

Timeframe: 30 days

Trial details

NCT IDNCT07363473

SponsorJC Medical, Inc., an affiliate of Edwards Lifesciences LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Sheri L Halverson, MPH

1-800-424-3278 Sheri_Halverson@Edwards.com

View on ClinicalTrials.gov More Aortic Valve Regurgitation trials