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The JOURNEY LVAD trial

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About the trial

About the trial

The JOURNEY LVAD trial will 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 regurgitation (AR).

Aortic regurgitation

Aortic Regurgitation (AR) is a known complication after LVAD implantation and compromises its benefits and impacts clinical outcomes.1 

Doctor with patient

LVAD-associated AR affects 25-30% of patients within one year of implantation and can contribute to recurrence of symptomatic heart failure (HF).² Patients with pre-existing AR usually deteriorate and those without can develop de novo AR after LVAD placement. 3,4

Study design

Study design

Eligibility criteria

  1. 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
  2. Symptomatic according to New York Heart Association (NYHA) functional class II or higher
  3. High risk for surgery as judged by a multi-disciplinary heart team
  4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices

Full inclusion and exclusion criteria are detailed in the clinical protocol

Study device

Edwards J-Valve TAVR-AR System

Study device
  1. 1
    Bovine pericardium leaflets
  2. 2
    Interconnecting suture
  3. 3
    Nitinol frame
  4. 4
    Anchor ring
  5. 5
    Latch (attachment to delivery device (x3))
  6. 6
    Grip feature (x6)

The J-Valve TAVR-AR system procedural animation

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We're here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center. 

For details about the trial, visit NCT07363473 at Clinical Trials.gov.

Give us a call

888.713.1564

Send us an email

patient_support@edwards.com

References

  1. Rali AS, Taduru SS, Tran LE, et al. Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement Outcomes in Left Ventricular Assist Device Patients with Aortic Insufficiency. Card Fail Rev. Jan 2022;8:e30. doi:10.15420/cfr.2022.21
  2. Bouabdallaoui N, El-Hamamsy I, Pham M, et al. Aortic regurgitation in patients with a left ventricular assist device: A contemporary review. The Journal of Heart and Lung Transplantation. 2018;37(11):1289-1297. doi:10.1016/j.healun.2018.07.002
  3. Acharya D, Kazui T, Al Rameni D, et al. Aortic valve disorders and left ventricular assist devices. Front Cardiovasc Med. 2023;10:1098348. doi:10.3389/fcvm.2023.1098348
  4. Vu V, May-Newman K. Aortic Insufficiency in LVAD Patients. InL Enkhsaikhan P, Hugo M, Jeffrey AT, Umar B, eds. Ventricular Assist Devices. IntechOpen; 2022:Ch.6.
CAUTION: Investigational device.

CAUTION: Investigational device. Limited by Federal (United States) law to investigational use. 

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