JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Regurgitation; Aortic Insufficiency; Aortic Valve Disease Mixed
• Intervention / Treatment: Device: J-Valve Transfemoral System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheri L Halverson, MPH; Phone Number: 1-800-424-3278; Email: sheri_halverson@edwards.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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 (see anatomic exclusions below)
5. Written informed consent and agreement to comply with all required follow-up visits at investigational site

Exclusion Criteria:

1. Prior aortic valve replacement or repair
2. Aortic valve stenosis > moderate as assessed by core lab
3. Severe mitral valve or tricuspid valve regurgitation as assessed by core lab
4. Severe mitral valve or tricuspid valve stenosis as assessed by core lab
5. Active infection requiring current antibiotic therapy, including infective endocarditis
6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation
7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
8. Renal insufficiency (eGFR <25 mL/min/1.73m2) or end stage renal disease requiring chronic dialysis
9. Cirrhosis (Child-Pugh Class B or C)
10. 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)
11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media which cannot be adequately premedicated
12. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure
13. Acute myocardial infarction within 30 days prior to index procedure
14. PCI within 30 days prior to index procedure
15. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
16. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
17. Uncontrolled atrial fibrillation
18. Severe right ventricular (RV) dysfunction or chronic inotrope support (>30 days)
19. Severe pulmonary hypertension (systolic pulmonary artery pressure >80 mmHg measured by right heart catheterization)
20. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen
21. 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
22. Estimated life expectancy of less than 12 months
23. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
24. Participation in another investigational study that has not reached its primary endpoint
25. Considered to be part of a vulnerable population

Anatomic Exclusions:

1. Ascending aortic diameter ≥5.5 cm as assessed by core lab
2. Aortic annulus perimeter <57 mm or >104 mm as assessed by core lab
3. Inappropriate anatomy for femoral introduction and delivery of the study system
4. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy as assessed by core lab
5. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
6. Excessive aortic valve prolapse or leaflet deterioration that would preclude proper seating of the implant in the aortic annulus
7. Abdominal/thoracic aortic aneurysm ≥5.0 cm as assessed by core lab
8. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
9. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, and/or LV-aortic root angle >80°

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: J-Valve Transfemoral System

Device: J-Valve Transfemoral System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	Freedom from moderate or severe total aortic regurgitation	30 days
Primary Safety Endpoint	Freedom from all-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valve embolization	Valve embolization	During index procedure
Need for second bioprosthetic valve	Need for second bioprosthetic valve	During index procedure
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	30 days compared with baseline

Collaborators and Investigators

• Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
• Investigators: Study Chair: Richard Cheng, MD, University of California, Los Angeles; Principal Investigator: Andrew Morse, MD, Ascension St. Thomas; Principal Investigator: Ulrich Jorde, MD, Montefiore Health System

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Transfemoral; TAVR; Left Ventricular Assist Device; LVAD; J-Valve Transfemoral System; Transcatheter Therapy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: JCM-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes