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J-Valve Transfemoral System for Aortic Valve Regurgitation

This study is testing the J-Valve Transfemoral (TF) System, a new device used for transcatheter aortic valve replacement (TAVR). This treatment is for people with severe aortic valve regurgitation (AR), a condition where the heart's aortic valve doesn't close properly, causing blood to leak backward. You might be able to join if you have symptoms like shortness of breath or fatigue (NYHA functional class II or higher) and your heart team believes you are at high risk for traditional open-heart surgery. The study aims to see how safe and effective the J-Valve TF System is. Researchers will look at how many people pass away within one year and how many experience certain safety issues within 30 days of the procedure. The study plans to enroll up to 194 participants.

Study design
This is a single-arm study, meaning all participants will receive the J-Valve Transfemoral (TF) System. It will involve up to 194 participants across multiple centers in the United States, Canada, Europe, and Japan.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after receiving the J-Valve TF System.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06455787

J-Valve Transfemoral Pivotal Study

Recruiting
NAAges 18+InterventionalTreatment
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
~194 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:J-Valve Transfemoral (TF) System

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All-cause mortality at 1 year
Measured over 1-year post-procedure
+1 more outcome measured

Conditions

Aortic Valve Regurgitation
Aortic Valve Disease Mixed

Explore related trials

Aortic Valve DisorderAortic Valve Insufficiency

Where it's being run

40 sites across 26 states
California5
New York4
Texas3
Georgia2
Illinois2
Massachusetts2
Minnesota2
Tennessee2

Study leadership

  • Dean J Kereiakes, MD · STUDY_CHAIR · The Christ Hospital Heart & Vascular Institute
  • Michael Reardon, MD · STUDY_CHAIR · The Methodist Hospital Research Institute
  • Santiago Garcia, MD · PRINCIPAL_INVESTIGATOR · The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education
  • Tsuyoshi Kaneko, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Sheri L Halverson, MPH
[email protected]
1-800-424-3278
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

As assessed by Imaging Core Laboratory
As assessed by Imaging Core Laboratory

What this trial measures

  • All-cause mortality at 1 year1-year post-procedure
  • The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3)30-days post-procedure

    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