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RECRUITING NA

J-Valve Transfemoral Pivotal Study

NCT06455787 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE J-Valve Transfemoral (TF) System

Study Locations (20)

California

  • Cedars Sinai — Los Angeles
  • Stanford University Medical Center — Palo Alto
  • Bay Area Structural Heart at Sutter Health — San Francisco
  • University of California San Francisco — San Francisco

Georgia

  • Emory University Atlanta — Atlanta
  • Piedmont — Atlanta

Illinois

  • Northwestern University Chicago — Chicago
  • Glenbrook - Endeavor Health — Glenview

Louisiana

  • Cardiovascular Institute of the South — Houma
  • Terrebonne General (CIS) — Houma

Massachusetts

  • Massachusetts General Hospital Boston — Boston
  • Brigham and Women's Hospital — Boston

Minnesota

  • Minneapolis Heart Institute Foundation — Minneapolis
  • CentraCare Heart and Vascular Center — Saint Cloud

Arizona

  • HonorHealth Research & Innovation Institute — Scottsdale

Colorado

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

Trial Details

FieldValue
Enrollment Target 194 participants
Start Date 2024-10-17
Est. Completion 2032-02
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06455787

The ClinicalTrials.gov registry entry for NCT06455787 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Aortic Valve Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which J-Valve Transfemoral (TF) System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06455787 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06455787 about?

NCT06455787 is a clinical study titled "J-Valve Transfemoral Pivotal Study". 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 t...

What is the current status of trial NCT06455787?

This trial is currently recruiting. It is a NA study. The enrollment target is 194 participants. The study started on 2024-10-17. Estimated completion is 2032-02.

What conditions does trial NCT06455787 study?

This clinical trial studies the following conditions: Aortic Valve Regurgitation, Aortic Valve Disease Mixed. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06455787?

The interventions under investigation include: J-Valve Transfemoral (TF) System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06455787?

This trial is sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06455787 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial