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Aortic Valve RegurgitationJOURNEYNCT06455787

J-Valve Transfemoral Pivotal Study

A study testing J-Valve Transfemoral (TF) System in people with Aortic Valve Regurgitation and Aortic Valve Disease Mixed, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 42 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
J-Valve Transfemoral (TF) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
42 sitesin 5 countries
Study dates
17 Oct 2024to Feb 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
  • Severe AR, defined as follows, as assessed by Imaging Core Laboratory:
  • Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4)
  • OR, if indeterminate AR, by TTE, ANY ONE of the following:
  • Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index [LVEDVi]) >105 mL/m^2 for men or LVEDVi >96 mL/m^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL/m^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4)
  • 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 post-procedure follow-up visits at investigational site.

Who cannot join

  • Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
  • Aortic valve stenosis > moderate*
  • Severe mitral valve or tricuspid valve regurgitation*
  • Severe mitral valve or tricuspid valve stenosis*
  • Active infection, including infective endocarditis
  • Cardiac imaging evidence of cardiac mass, thrombus or vegetation
Show all 42Show fewer
  • Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
  • Renal insufficiency (eGFR <30 mL/min/1.73m^2) or end stage renal disease requiring chronic dialysis
  • Liver disease (cirrhosis of the liver [Child-Pugh Class B or C])
  • Blood dyscrasias as defined: 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
  • Left ventricular dysfunction with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram (or by CMR, when performed)*
  • 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*
  • Pulmonary hypertension (systolic PA pressure >70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
  • Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
  • Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
  • Cardiogenic shock defined as systolic blood pressure <90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg
  • Patient requires mechanical circulatory support within 30 days prior to index procedure
  • Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
  • 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
  • As assessed by Imaging Core Laboratory
  • Anatomic Exclusions:
  • Ascending Aortic diameter >5 cm*
  • Aortic Annulus Perimeter <57 mm or >104 mm*
  • Inappropriate anatomy for femoral introduction and delivery of the study system
  • Left ventricular end-diastolic diameter (LVEDD) >75 mm*
  • Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy*
  • Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
  • Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
  • Abdominal/thoracic aortic aneurysm ≥5.0 cm*
  • Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
  • Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle >80⁰
  • Non-native anatomy in aortic zones 0A \& 0B (aortic valve annulus to the distal margin of the right pulmonary artery); 0C (to innominate) only if deemed unfavorable by the Study Screening Committee
  • As assessed by Imaging Core Laboratory

Trial locations and contacts

42 sites in 5 countries.

42 sites in 5 countries

United States35 sites

  • Emory University Atlanta

    Atlanta, Georgia, 30308

  • Piedmont

    Atlanta, Georgia, 30309

  • Massachusetts General Hospital Boston

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University at Buffalo - Kaleida Health

    Buffalo, New York, 14203

  • Carolinas Health System (Atrium)

    Charlotte, North Carolina, 28204

  • Northwestern University Chicago

    Chicago, Illinois, 60611

  • The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education

    Cincinnati, Ohio, 45219

  • Henry Ford Hospital Detroit

    Detroit, Michigan, 48202

  • Glenbrook - Endeavor Health

    Glenview, Illinois, 60026

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Scripps Memorial Hospital La Jolla

    La Jolla, California, 92037

  • Cedars Sinai

    Los Angeles, California, 90048

  • UC Health Northern Colorado (Medical Center of the Rockies)

    Loveland, Colorado, 80538

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • NCH Rooney Heart Institute

    Naples, Florida, 34102

  • Ascension St. Thomas West Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia University Irving Medical Center/New York-Presbyterian Hospital

    New York, New York, 10032

  • Stanford University Medical Center

    Palo Alto, California, 94394

  • Banner University Medical Center - Phoenix

    Phoenix, Arizona, 85006

  • The Heart Hospital - Baylor Plano

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • St. Francis Hospital

    Roslyn, New York, 11576

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

  • Bay Area Structural Heart at Sutter Health

    San Francisco, California, 94109

  • University of California San Francisco

    San Francisco, California, 94143

  • HonorHealth Research & Innovation Institute

    Scottsdale, Arizona, 85258

  • Swedish Heart & Vascular Research

    Seattle, Washington, 98122

  • Washington University - Barnes-Jewish Hospital St. Louis

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Washington Hospital Center DC

    Washington D.C., District of Columbia, 20010

  • Ascension Via Christi

    Wichita, Kansas, 67214

Other trials in United States

Japan3 sites

  • National Cerebral and Cardiovascular Center

    Osaka, 5488565

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 160-8582

  • Keio University Hospital

    Tokyo, Shinjuku-Ku, 160-8582

Other trials in Japan

Canada2 sites

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

  • St. Paul's Hospital Vancouver

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

France1 site

  • Clinique Pasteur Toulouse

    Toulouse, 31076

Other trials in France

United Kingdom1 site

  • Oxford - John Radcliff Hospital

    Oxford, OX3 9DU

Other trials in United Kingdom

About this study

Official title: J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Read the detailed description

This is a prospective, single arm, multi-center, interventional pivotal study that will enroll up to 194 subjects in up to 35 investigational sites, predominantly in the United States and up to 7 in Canada, Europe, and Japan. Of the 194 subjects, the CMR imaging sub-study will include up to 75 subjects with severe AR already confirmed by TTE. Additionally, up to 40 roll-in subjects may be treated to enable clinical experience and exposure to the device while allowing a reasonable learning curve. The subjects will then be followed 5-years post-procedure of the J-Valve TF System.

Being tested
J-Valve Transfemoral (TF) System
Keywords
J-Valve Transfemoral System, Transcatheter Therapy, Transcatheter Aortic Valve Replacement, TAVR, Transfemoral
Medical subject headings
Aortic Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • J-Valve Transfemoral (TF) SystemDevice

    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.

Study groups in NCT06455787
Study groupRoleWhat they receive
J-Valve Transfemoral (TF) SystemExperimentalNot described
Receives: Device: J-Valve Transfemoral (TF) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality at 1 year

    Measured: 1-year post-procedure

  2. The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3)

    Includes:

    • All-cause death
    • All stroke
    • VARC-3 type 2-4 bleeding
    • Major vascular, access-related, or cardiac structural complication
    • Acute kidney injury (AKI) stage 3 or 4
    • New permanent pacemaker due to procedure-related conduction abnormalities
    • Surgery or intervention related to the device

    Measured: 30-days post-procedure

Secondary outcomes (5)

  1. Rate of improvement in cardiovascular-specific health status

    As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS)

    Measured: Baseline to 1-year follow-up

  2. Improvement in left ventricular end diastolic diameter index (LVEDDi)

    To measure LV remodeling

    Measured: Baseline to 1-year follow-up

  3. Improvement in left ventricular end diastolic volume index (LVEDVi)

    To measure LV remodeling

    Measured: Baseline to 1-year follow-up

  4. Improvement in effective stroke volume index (ESVi)

    To measure LV remodeling

    Measured: Baseline to 1-year follow-up

  5. Improvement in effective cardiac output index (ECOi)

    To measure LV remodeling

    Measured: Baseline to 1-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start17 Oct 2024
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The investigation is a prospective, single arm, multi-center, interventional pivotal study.
Masking
None (open label)
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455787
Sponsor's protocol ID
JCM-002
Acronym
JOURNEY
Status last verified
Oct 2026
First submitted
7 Jun 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing J-Valve Transfemoral (TF) System in people with Aortic Valve Regurgitation and Aortic Valve Disease Mixed, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Japan, Canada, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality at 1 year (time frame: 1-year post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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