JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

Starting soon · Not applicable

Conditions studied: Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency

In brief

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).

Key facts

Study ID

NCT07363473

Run by

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

People needed

50

Starts

2026-04-01

Expected to finish

2029-11-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
• 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
• Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
• Uncontrolled atrial fibrillation
• Severe right ventricular (RV) dysfunction or chronic inotrope support (>30 days)
• Severe pulmonary hypertension (systolic pulmonary artery pressure >80 mmHg measured by right heart catheterization)
• Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen
• Stroke (cerebrovascular accident, CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
• Estimated life expectancy of less than 12 months
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
• Participation in another investigational study that has not reached its primary endpoint
• Considered to be part of a vulnerable population

Full record on ClinicalTrials.gov

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