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China 3T MRI Study

Primary Purpose

Bradycardia, Tachycardia, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
China market released 3.0T Magnetic resonance (MR) conditional CIED systems
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

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

Inclusion Criteria: Subjects who were implanted an SureScan system CIED over 6 weeks at the time of signing ICF. Subjects who are able and willing to undergo elective MRI scanning without sedation. Subjects who were implanted an SureScan system CIED in the pectoral region. Subjects who are geographically stable and available for follow-up at the study site for the length of the study. Subjects who are at least 18 years of age (or older, if required by local law). Exclusion Criteria: Subjects who require a legally authorized representative to obtain informed consent. Subjects with abandoned or capped leads. Subjects who require an indicated MRI scan, other than those specifically described in the China CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up. Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys). Subjects with medical conditions that preclude the testing required by the CIP or limit study participation. Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the SureScan study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans

    Arm Description

    Signal arm, To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment

    Outcomes

    Primary Outcome Measures

    The occurrence of an MRI-related event for CIED
    The occurrence of any of the following within 30 days after the 3.0T MRI visit will be considered an MRI-related event for CIED: Medical advisor-assessed MRI-related complication within 30 days post-MRI Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock) as assessed by a medical advisor.

    Secondary Outcome Measures

    The changes in atrial and ventricular pacing capture thresholds of APCT from pre-MRI to 1-month post-MRI scan.
    PCTs to be evaluated include: Atrial pacing capture threshold (if applicable)
    The changes in atrial and ventricular pacing capture thresholds of VPCT from pre-MRI to 1-month post-MRI scan.
    PCTs to be evaluated include: Ventricular pacing capture threshold (both right and left ventricular lead if applicable)

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Medtronic Cardiac Rhythm and Heart Failure
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06038123
    Brief Title
    China 3T MRI Study
    Official Title
    China CIED 3.0T MRI Performance Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 7, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Cardiac Rhythm and Heart Failure

    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 China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans. ll subjects will have required follow-up visits at baseline, MRI visit, 1-month post-MRI. The MRI scans will occur at the MRI visit. The MRI scan region will be determined by investigator according to the subject's clinical condition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bradycardia, Tachycardia, Heart Failure

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans
    Arm Type
    Experimental
    Arm Description
    Signal arm, To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment
    Intervention Type
    Device
    Intervention Name(s)
    China market released 3.0T Magnetic resonance (MR) conditional CIED systems
    Intervention Description
    To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment when subjects receive 3.0T MRI scans without positioning restrictions (MRI scans may occur anywhere on the body)
    Primary Outcome Measure Information:
    Title
    The occurrence of an MRI-related event for CIED
    Description
    The occurrence of any of the following within 30 days after the 3.0T MRI visit will be considered an MRI-related event for CIED: Medical advisor-assessed MRI-related complication within 30 days post-MRI Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock) as assessed by a medical advisor.
    Time Frame
    The event will be collected within 30 days after MRI visit.
    Secondary Outcome Measure Information:
    Title
    The changes in atrial and ventricular pacing capture thresholds of APCT from pre-MRI to 1-month post-MRI scan.
    Description
    PCTs to be evaluated include: Atrial pacing capture threshold (if applicable)
    Time Frame
    The evaluation will be compared from pre-MRI to 1-month post-MRI scan
    Title
    The changes in atrial and ventricular pacing capture thresholds of VPCT from pre-MRI to 1-month post-MRI scan.
    Description
    PCTs to be evaluated include: Ventricular pacing capture threshold (both right and left ventricular lead if applicable)
    Time Frame
    The evaluation will be compared from pre-MRI to 1-month post-MRI scan

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who were implanted an SureScan system CIED over 6 weeks at the time of signing ICF. Subjects who are able and willing to undergo elective MRI scanning without sedation. Subjects who were implanted an SureScan system CIED in the pectoral region. Subjects who are geographically stable and available for follow-up at the study site for the length of the study. Subjects who are at least 18 years of age (or older, if required by local law). Exclusion Criteria: Subjects who require a legally authorized representative to obtain informed consent. Subjects with abandoned or capped leads. Subjects who require an indicated MRI scan, other than those specifically described in the China CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up. Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys). Subjects with medical conditions that preclude the testing required by the CIP or limit study participation. Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the SureScan study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Tang, Master
    Phone
    +86 15921265787
    Email
    peter.tang@medtronic.com

    12. IPD Sharing Statement

    Learn more about this trial

    China 3T MRI Study

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