J-Valve Transfemoral Pivotal Study

NCT06455787 | Recruiting DMC FDA Device

• 1 other identifier: JCM-002
• Study Type: interventional
• Target: 194
• Locations: 5 countries
• Sites: 40

Brief 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 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.

Conditions

Aortic Valve Regurgitation; Aortic Valve Disease Mixed

Keywords

J-Valve Transfemoral System; Transcatheter Therapy; Transcatheter Aortic Valve Replacement; TAVR; Transfemoral

Outcome Measures

Primary Outcomes (2)

• All-cause mortality at 1 year

  1-year post-procedure

• 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

Secondary Outcomes (5)

• Rate of improvement in cardiovascular-specific health status

  Baseline to 1-year follow-up

• Improvement in left ventricular end diastolic diameter index (LVEDDi)

  Baseline to 1-year follow-up

• Improvement in left ventricular end diastolic volume index (LVEDVi)

  Baseline to 1-year follow-up

• Improvement in effective stroke volume index (ESVi)

  Baseline to 1-year follow-up

• Improvement in effective cardiac output index (ECOi)

  Baseline to 1-year follow-up

Study Arms (1)

J-Valve Transfemoral (TF) System

EXPERIMENTAL

Device: J-Valve Transfemoral (TF) System

Interventions

J-Valve Transfemoral (TF) System DEVICE

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.

J-Valve Transfemoral (TF) System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• High risk for surgery as judged by a multi-disciplinary heart team
• Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• JC Medical, Inc., an affiliate of Edwards Lifesciences LLC: lead
• Cardiovascular Research Foundation, New York: collaborator
• Minneapolis Heart Institute Foundation: collaborator

Study Sites (40)

HonorHealth Research & Innovation Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

RECRUITING

Cedars Sinai

Los Angeles, California, 90048, United States

RECRUITING

Stanford University Medical Center

Palo Alto, California, 94394, United States

RECRUITING

Bay Area Structural Heart at Sutter Health

San Francisco, California, 94109, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

UC Health Northern Colorado (Medical Center of the Rockies)

Loveland, Colorado, 80538, United States

RECRUITING

Washington Hospital Center DC

Washington D.C., District of Columbia, 20010, United States

RECRUITING

NCH Rooney Heart Institute

Naples, Florida, 34102, United States

RECRUITING

Emory University Atlanta

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont

Atlanta, Georgia, 30309, United States

RECRUITING

Northwestern University Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Glenbrook - Endeavor Health

Glenview, Illinois, 60026, United States

RECRUITING

Ascension Via Christi

Wichita, Kansas, 67214, United States

RECRUITING

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

Massachusetts General Hospital Boston

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Hospital Detroit

Detroit, Michigan, 48202, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

RECRUITING

Washington University - Barnes-Jewish Hospital St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

University at Buffalo - Kaleida Health

Buffalo, New York, 14203, United States

RECRUITING

Columbia University Irving Medical Center/New York-Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

St. Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Carolinas Health System (Atrium)

Charlotte, North Carolina, 28204, United States

RECRUITING

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

Cincinnati, Ohio, 45219, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Ascension St. Thomas West Hospital

Nashville, Tennessee, 37205, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

The Heart Hospital - Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

Swedish Heart & Vascular Research

Seattle, Washington, 98122, United States

RECRUITING

St. Paul's Hospital Vancouver

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

Clinique Pasteur Toulouse

Toulouse, 31076, France

RECRUITING

Juntendo University Hospital

Tokyo, Bunkyo-ku, 160-8582, Japan

RECRUITING

Keio University Hospital

Tokyo, Shinjuku-Ku, 160-8582, Japan

RECRUITING

Oxford - John Radcliff Hospital

Oxford, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Dean J Kereiakes, MD

  The Christ Hospital Heart & Vascular Institute

  STUDY CHAIR

• Michael Reardon, MD

  The Methodist Hospital Research Institute

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheri L Halverson, MPH

CONTACT

1-800-424-3278; sheri_halverson@edwards.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The investigation is a prospective, single arm, multi-center, interventional pivotal study.

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2032
• Last Updated: May 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); FR (1); CA (2); JP (2); GB (1)