J-Valve Transfemoral Pivotal Study (JOURNEY)

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Regurgitation; Aortic Valve Disease Mixed
• Intervention / Treatment: Device: J-Valve Transfemoral (TF) System

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.

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • Recruiting
      • St. Paul's Hospital Vancouver
      • Principal Investigator: John Webb, MD
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • Recruiting
      • St. Michael's Hospital
      • Principal Investigator: Neil Fam, MD
• France
  • Toulouse, France, 31076
    • Recruiting
    • Clinique Pasteur Toulouse
    • Principal Investigator: Didier Tchetche, MD
• Japan
  • Bunkyo-ku
    • Tokyo, Bunkyo-ku, Japan, 160-8582
      • Recruiting
      • Juntendo University Hospital
      • Principal Investigator: Minoru Tabata, MD
  • Shinjuku-Ku
    • Tokyo, Shinjuku-Ku, Japan, 160-8582
      • Recruiting
      • Keio University Hospital
      • Principal Investigator: Yohei Numasawa, MD
• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • Oxford - John Radcliff Hospital
    • Principal Investigator: Sam Dawkins, MD
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • HonorHealth Research & Innovation Institute
      • Principal Investigator: Andrew Cluckey, MD
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Scripps Memorial Hospital La Jolla
      • Principal Investigator: Curtiss Stinis, MD
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai
      • Principal Investigator: Raj Makkar, MD
    • Palo Alto, California, United States, 94394
      • Recruiting
      • Stanford University Medical Center
      • Principal Investigator: John MacArthur, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Principal Investigator: Sammy Elmariah, MD
    • San Francisco, California, United States, 94109
      • Recruiting
      • Bay Area Structural Heart at Sutter Health
      • Principal Investigator: David Daniels, MD
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Recruiting
      • UC Health Northern Colorado (Medical Center of the Rockies)
      • Principal Investigator: Mark Tuttle, MD
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Washington Hospital Center DC
      • Principal Investigator: Ron Waksman, MD
  • Florida
    • Naples, Florida, United States, 34102
      • Recruiting
      • NCH Rooney Heart Institute
      • Principal Investigator: Robert Cubeddu, MD
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Atlanta
      • Principal Investigator: Vasilis Babaliaros, MD
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont
      • Principal Investigator: Vinod Thourani, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Chicago
      • Principal Investigator: Anita Asgar, MD
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Glenbrook - Endeavor Health
      • Principal Investigator: Mark Ricciardi, MD
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Ascension Via Christi
      • Principal Investigator: Bassem Chehab, MD
      • Sub-Investigator: Brett Grizzell, MD
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Recruiting
      • Cardiovascular Institute of the South
      • Principal Investigator: Peter Fail, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Principal Investigator: Pinak Shah, MD
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital Boston
      • Principal Investigator: Ignacio Inglessis-Azuaje, MD
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital Detroit
      • Principal Investigator: Pedro Villablanca, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Principal Investigator: Konstantinos Voudris, MD
    • Saint Cloud, Minnesota, United States, 56303
      • Recruiting
      • Centracare Heart and Vascular Center
      • Principal Investigator: Brian Stegman, MD
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University - Barnes-Jewish Hospital St. Louis
      • Principal Investigator: Alan Zajarias, MD
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo - Kaleida Health
      • Principal Investigator: Vijay Iyer, MD
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center/New York-Presbyterian Hospital
      • Principal Investigator: Susheel Kodali, MD
    • Roslyn, New York, United States, 11576
      • Recruiting
      • St. Francis Hospital
      • Principal Investigator: George Petrossian, MD
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Principal Investigator: Mohamed A Latib, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Carolinas Health System (Atrium)
      • Principal Investigator: Jonathan Schwartz, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education
      • Principal Investigator: Santiago Garcia, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Principal Investigator: Harsh Golwala, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Principal Investigator: Brian Lindman, MD
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Ascension St. Thomas West Hospital
      • Principal Investigator: Andrew Morse, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Principal Investigator: Sachin Goel, MD
    • Houston, Texas, United States, 77004
      • Recruiting
      • HCA Houston Healthcare Medical Center
      • Principal Investigator: Pravac Loyalka, MD
    • Plano, Texas, United States, 75093
      • Recruiting
      • The Heart Hospital - Baylor Plano
      • Principal Investigator: Molly Szerlip, MD
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Heart & Vascular Research
      • Principal Investigator: Sameer A Gafoor, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher

2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:

   A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4)

   B. OR, if indeterminate AR, by TTE, ANY ONE of the following:

   i. 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)

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 post-procedure follow-up visits at investigational site.

Exclusion Criteria:

1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
2. Aortic valve stenosis > moderate*
3. Severe mitral valve or tricuspid valve regurgitation*
4. Severe mitral valve or tricuspid valve stenosis*
5. Active infection, 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 <30 mL/min/1.73m^2) or end stage renal disease requiring chronic dialysis
9. Liver disease (cirrhosis of the liver [Child-Pugh Class B or C])
10. 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)
11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated
12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram (or by CMR, when performed)*
13. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
14. Acute myocardial infarction within 30 days prior to index procedure
15. PCI within 30 days prior to index procedure
16. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
17. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
18. Uncontrolled atrial fibrillation
19. Severe right ventricular (RV) dysfunction*
20. Pulmonary hypertension (systolic PA pressure >70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
22. Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
23. 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
24. Patient requires mechanical circulatory support within 30 days prior to index procedure
25. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
27. Participation in another investigational study that has not reached its primary endpoint

28. Considered to be part of a vulnerable population

    • As assessed by Imaging Core Laboratory

Anatomic Exclusions:

1. Ascending Aortic diameter >5 cm*
2. Aortic Annulus Perimeter <57 mm or >104 mm*
3. Inappropriate anatomy for femoral introduction and delivery of the study system
4. Left ventricular end-diastolic diameter (LVEDD) >75 mm*
5. Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy*
6. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
7. Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
8. Abdominal/thoracic aortic aneurysm ≥5.0 cm*
9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
10. 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

11. 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

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 (TF) System

Device: J-Valve Transfemoral (TF) 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
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	30-days post-procedure
All-cause mortality at 1 year		1-year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of improvement in cardiovascular-specific health status	As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS)	Baseline to 1-year follow-up
Improvement in left ventricular end diastolic volume index (LVEDVi)	To measure LV remodeling	Baseline to 1-year follow-up
Improvement in left ventricular end diastolic diameter index (LVEDDi)	To measure LV remodeling	Baseline to 1-year follow-up
Improvement in effective stroke volume index (ESVi)	To measure LV remodeling	Baseline to 1-year follow-up
Improvement in effective cardiac output index (ECOi)	To measure LV remodeling	Baseline to 1-year follow-up

Collaborators and Investigators

• Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
• Collaborators: Cardiovascular Research Foundation, New York; Minneapolis Heart Institute Foundation
• Investigators: Study Chair: Michael Reardon, MD, The Methodist Hospital Research Institute; Study Chair: Dean J Kereiakes, MD, The Christ Hospital Heart & Vascular Institute; Principal Investigator: Santiago Garcia, MD, The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education; Principal Investigator: Tsuyoshi Kaneko, MD, Washington University School of Medicine

Publications and helpful links

Helpful Links

• JC Medical, Inc. company website.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; Transfemoral; TAVR; J-Valve Transfemoral System; Transcatheter Therapy
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Insufficiency; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: JCM-002

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
• product manufactured in and exported from the U.S.: No