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The MAGiC™ Cardiac Ablation European Study (MAGiC-FEST)

Primary Purpose

Arrhythmias, Cardiac

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MAGiC™
Sponsored by
Stereotaxis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias, Cardiac focused on measuring Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia, Supraventricular Tachycardia, Ablation, Premature Ventricular Contractions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult (aged 18 or older at time of consent); Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, with at least one (1) documented episode of the tachyarrhythmia to be treated within the previous six (6) months; Able to be safely exposed to magnetic fields; Willing and capable to attend scheduled follow up visits at the investigational site for the study duration (up to 12 months) Willing and able to provide informed consent. Exclusion Criteria: Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure) Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time Weight exceeding 200 kg (the weight limit of the table) For female patients of childbearing potential: pregnancy at the time of the procedure or unwilling to take a pregnancy test Presence of intracardiac thrombus at the time of the procedure Where MAGiC would need to cross a prosthetic valve Use of MAGiC in the coronary arteries A history of sensitivity to foreign objects or extreme allergies Acute illness or active systemic infection Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection Hemodynamic instability Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation Acute myocardial infarct (within the previous 30 days) Recent cardiac surgery (within the previous 60 days) Unstable angina History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days Previous cardiac ablation within the previous 30 days Concomitant arrhythmia(s) requiring active treatment at this time or in the 90 days prior to enrollment (Day -90 to Day 0) Currently or in the 30 days prior to consent, participation in an interventional clinical trial Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study (limitation on survival). Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation. For Atrial Fibrillation only: persistent Atrial Fibrillation (continuous Atrial Fibrillation lasting longer than 7 days) For Atrial Fibrillation only: Presence of any device that would interfere with planned access: Patent Foramen Ovale occlusion/closure device, patch

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Magnetic Interventional Ablation Catheter (MAGiC™)

    Outcomes

    Primary Outcome Measures

    Acute Performance
    The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
    Acute Safety
    Freedom from major adverse events (MAE) related to MAGiC.

    Secondary Outcome Measures

    Chronic Success
    Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
    Safety Events
    Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
    Onset of Procedure-related New Arrhythmia
    Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Stereotaxis
    Collaborators
    Osypka AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06019845
    Brief Title
    The MAGiC™ Cardiac Ablation European Study
    Acronym
    MAGiC-FEST
    Official Title
    The MAGiC™ Cardiac Ablation Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stereotaxis
    Collaborators
    Osypka AG

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. After MAGiC obtains European approval, the study will be amended and expanded to collect Post-Market Clinical Follow-up data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmias, Cardiac
    Keywords
    Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia, Supraventricular Tachycardia, Ablation, Premature Ventricular Contractions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Magnetic Interventional Ablation Catheter (MAGiC™)
    Intervention Type
    Device
    Intervention Name(s)
    MAGiC™
    Intervention Description
    Robotic magnetic radiofrequency (RF) ablation catheter
    Primary Outcome Measure Information:
    Title
    Acute Performance
    Description
    The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
    Time Frame
    hospital discharge - up to 7 days post procedure
    Title
    Acute Safety
    Description
    Freedom from major adverse events (MAE) related to MAGiC.
    Time Frame
    hospital discharge - up to 7 days post procedure
    Secondary Outcome Measure Information:
    Title
    Chronic Success
    Description
    Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
    Time Frame
    3 months, 6 months, 12 months
    Title
    Safety Events
    Description
    Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
    Time Frame
    3 months, 6 months, 12 months
    Title
    Onset of Procedure-related New Arrhythmia
    Description
    Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.
    Time Frame
    3 months, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult (aged 18 or older at time of consent); Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, with at least one (1) documented episode of the tachyarrhythmia to be treated within the previous six (6) months; Able to be safely exposed to magnetic fields; Willing and capable to attend scheduled follow up visits at the investigational site for the study duration (up to 12 months) Willing and able to provide informed consent. Exclusion Criteria: Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure) Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time Weight exceeding 200 kg (the weight limit of the table) For female patients of childbearing potential: pregnancy at the time of the procedure or unwilling to take a pregnancy test Presence of intracardiac thrombus at the time of the procedure Where MAGiC would need to cross a prosthetic valve Use of MAGiC in the coronary arteries A history of sensitivity to foreign objects or extreme allergies Acute illness or active systemic infection Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection Hemodynamic instability Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation Acute myocardial infarct (within the previous 30 days) Recent cardiac surgery (within the previous 60 days) Unstable angina History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days Previous cardiac ablation within the previous 30 days Concomitant arrhythmia(s) requiring active treatment at this time or in the 90 days prior to enrollment (Day -90 to Day 0) Currently or in the 30 days prior to consent, participation in an interventional clinical trial Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study (limitation on survival). Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation. For Atrial Fibrillation only: persistent Atrial Fibrillation (continuous Atrial Fibrillation lasting longer than 7 days) For Atrial Fibrillation only: Presence of any device that would interfere with planned access: Patent Foramen Ovale occlusion/closure device, patch
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephanie Buech
    Phone
    314-678-6100
    Email
    stephanie.buech@stereotaxis.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ioana Gruchevska
    Phone
    314-678-6217
    Email
    ioana.gruchevska@stereotaxis.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephanie Buech
    Organizational Affiliation
    Stereotaxis
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The MAGiC™ Cardiac Ablation European Study

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