China 3T MRI Study

Study Overview
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Brief Summary
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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.

Official Title
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China CIED 3.0T MRI Performance Study

Conditions
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Bradycardia, Tachycardia, Heart Failure

Intervention / Treatment
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* Device: China market released 3.0T Magnetic resonance (MR) conditional CIED systems


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with market released 3.0T conditional CIED systems receive 3.0T MRI scans<br>Signal arm, To confirm safety and effectiveness of the SureScan CIED System in the clinical MRI environment | Device: China market released 3.0T Magnetic resonance (MR) conditional CIED systems<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The event will be collected within 30 days after MRI visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 evaluation will be compared from pre-MRI to 1-month post-MRI scan | 
| 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) | The evaluation will be compared from pre-MRI to 1-month post-MRI scan |