JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

NCT07363473 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: JCM-003
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

J-Valve Transfemoral System; Transcatheter Therapy; Transcatheter Aortic Valve Replacement; TAVR; Transfemoral; Left Ventricular Assist Device; LVAD

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Freedom from moderate or severe total aortic regurgitation

  30 days

• Primary Safety Endpoint

  Freedom from all-cause mortality

  30 days

Secondary Outcomes (3)

• Valve embolization

  During index procedure

• Need for second bioprosthetic valve

  During index procedure

• Change in cardiovascular-specific health status

  30 days compared with baseline

Study Arms (1)

J-Valve Transfemoral System

EXPERIMENTAL

Device: J-Valve Transfemoral System

Interventions

J-Valve Transfemoral System DEVICE

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.

J-Valve Transfemoral System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent and agreement to comply with all required follow-up visits at investigational site

You may not qualify if:

• 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
• Renal insufficiency (eGFR \<25 mL/min/1.73m2) or end stage renal disease requiring chronic dialysis
• Cirrhosis (Child-Pugh Class B or C)
• Leukopenia (WBC \<3000 cells/mcL), thrombocytopenia (platelet count \<50,000 cells/mcL), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis, coagulopathy, or hypercoagulable state (unless therapeutically stable)
• Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media which cannot be adequately premedicated
• Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure
• Acute myocardial infarction within 30 days prior to index procedure
• PCI within 30 days prior to index procedure
• Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention

Sponsors & Collaborators

• JC Medical, Inc., an affiliate of Edwards Lifesciences LLC: lead

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Richard Cheng, MD

  University of California, Los Angeles

  STUDY CHAIR

• Andrew Morse, MD

  Ascension St. Thomas

  PRINCIPAL INVESTIGATOR

• Ulrich Jorde, MD

  Montefiore Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheri L Halverson, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation is a prospective, single arm, multi-center, interventional pivotal study

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share