JOURNEY LVAD: JOURNEY Left Ventricular Assist Device

March 3, 2026 updated by: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 30 days
Freedom from moderate or severe total aortic regurgitation
30 days
Primary Safety Endpoint
Time Frame: 30 days
Freedom from all-cause mortality
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Valve embolization
Time Frame: During index procedure
Valve embolization
During index procedure
Need for second bioprosthetic valve
Time Frame: During index procedure
Need for second bioprosthetic valve
During index procedure
Change in cardiovascular-specific health status
Time Frame: 30 days compared with baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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