New valve device could fix leaky heart valve without open surgery

NCT ID NCT06455787

Disease control Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new device called the J-Valve, which is a replacement heart valve delivered through a tube in the leg, to treat severe aortic regurgitation (a leaky heart valve). The trial will include 194 people with severe symptoms who are at high risk for open-heart surgery. The goal is to see if the device is safe and effective at improving heart function and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: J-Valve Transfemoral (TF) System (a replacement heart valve delivered through a tube in the leg)
What this could lead to: If it works, this could offer a less invasive treatment option for people with severe aortic regurgitation who are too high-risk for open-heart surgery.
What could go wrong: This is an early study with no phase designation, so results are uncertain. Risks include death, stroke, bleeding, and need for a permanent pacemaker.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 194 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic valve disorder aortic valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve disease mixed Aortic valve regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

40 sites in 5 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ascension St. Thomas West Hospital
RECRUITING

Nashville, Tennessee, 37205, United States
Ascension Via Christi
RECRUITING

Wichita, Kansas, 67214, United States
Bay Area Structural Heart at Sutter Health
RECRUITING

San Francisco, California, 94109, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Cardiovascular Institute of the South
RECRUITING

Houma, Louisiana, 70360, United States
Carolinas Health System (Atrium)
RECRUITING

Charlotte, North Carolina, 28204, United States
Cedars Sinai
RECRUITING

Los Angeles, California, 90048, United States
CentraCare Heart and Vascular Center
RECRUITING

Saint Cloud, Minnesota, 56303, United States
Clinique Pasteur Toulouse
RECRUITING

Toulouse, 31076, France
Columbia University Irving Medical Center/New York-Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Emory University Atlanta
RECRUITING

Atlanta, Georgia, 30308, United States
Glenbrook - Endeavor Health
RECRUITING

Glenview, Illinois, 60026, United States
HCA Houston Healthcare Medical Center
RECRUITING

Houston, Texas, 77004, United States
Henry Ford Hospital Detroit
RECRUITING

Detroit, Michigan, 48202, United States
HonorHealth Research & Innovation Institute
RECRUITING

Scottsdale, Arizona, 85258, United States
Houston Methodist Hospital
RECRUITING

Houston, Texas, 77030, United States
Juntendo University Hospital
RECRUITING

Tokyo, Bunkyo-ku, 160-8582, Japan
Keio University Hospital
RECRUITING

Tokyo, Shinjuku-Ku, 160-8582, Japan
Massachusetts General Hospital Boston
RECRUITING

Boston, Massachusetts, 02114, United States
Minneapolis Heart Institute Foundation
RECRUITING

Minneapolis, Minnesota, 55407, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
NCH Rooney Heart Institute
RECRUITING

Naples, Florida, 34102, United States
Northwestern University Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States
Oxford - John Radcliff Hospital
RECRUITING

Oxford, OX3 9DU, United Kingdom
Piedmont
RECRUITING

Atlanta, Georgia, 30309, United States
Scripps Memorial Hospital La Jolla
RECRUITING

La Jolla, California, 92037, United States
St. Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
St. Michael's Hospital
RECRUITING

Toronto, Ontario, M5B1W8, Canada
St. Paul's Hospital Vancouver
RECRUITING

Vancouver, British Columbia, V6Z1Y6, Canada
Stanford University Medical Center
RECRUITING

Palo Alto, California, 94394, United States
Swedish Heart & Vascular Research
RECRUITING

Seattle, Washington, 98122, United States
The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education
RECRUITING

Cincinnati, Ohio, 45219, United States
The Heart Hospital - Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
UC Health Northern Colorado (Medical Center of the Rockies)
RECRUITING

Loveland, Colorado, 80538, United States
University at Buffalo - Kaleida Health
RECRUITING

Buffalo, New York, 14203, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94143, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Washington Hospital Center DC
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Washington University - Barnes-Jewish Hospital St. Louis
RECRUITING

St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.