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J-Valve Compassionate Use

Primary Purpose

Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Transcatheter Aortic Valve Replacement
Sponsored by
JC Medical, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Aortic Valve Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2019
    Last Updated
    April 25, 2023
    Sponsor
    JC Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03876964
    Brief Title
    J-Valve Compassionate Use
    Official Title
    J-Valve Compassionate Use Cases
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    JC Medical, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
    Detailed Description
    The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Transcatheter Aortic Valve Replacement
    Other Intervention Name(s)
    TAVR
    Intervention Description
    Minimally invasive replacement of the aortic valve through a catheter.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: - Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dennis M McMahon, MD
    Phone
    650-477-2781
    Ext
    7601
    Email
    dmcmahon@jcmedicalinc.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chris Yang, PhD
    Phone
    650-477-2781
    Email
    cyang@jcmedicalinc.com

    12. IPD Sharing Statement

    Learn more about this trial

    J-Valve Compassionate Use

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