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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. All 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with market released 3.0T conditional CIED systems undergoing 3.0T MRI scan attempt | Experimental | This was a single-arm study 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). Study devices refer to China market released 3.0T Magnetic resonance (MR) conditional CIED systems. Subjects implanted with a SureScan study device who underwent a 3.0T MRI scan attempt were considered in endpoint analyses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| China market released 3.0T Magnetic resonance (MR) conditional CIED systems | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The Occurrence of an MRI-related Event for CIED | The primary objective was to demonstrate the safety of SureScan system CIED in clinical 3.0T MRI environment within 1-month post-MRI scan. Specifically, it was hypothesized that the MRI-related event-free rate within 1-month post-MRI to be greater than 90%. The proportion of subjects free from MRI-related events was calculated by dividing the number of subjects without an MRI-related event by the number of subjects at risk for an event. The occurrence of any of the following within 30 days after a 3.0T MRI scan would be considered an MRI-related event: (1) Medical advisor-assessed MRI-related complication within 30 days post-MRI (for iPG, ICD or CRT-D); (2) Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI (for iPG, ICD or CRT-D); (3) Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock), as assessed by a medical advisor (for ICD or CRT-D). | The event will be collected within 30 days after MRI visit. |
| Measure | Description | Time Frame |
|---|---|---|
| The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan. | There was no hypothesis for this secondary objective. Pacing capture thresholds (PCTs) to be characterized include: APCT of atrial lead for subjects with an IPG device; APCT of atrial lead and VPCT of right ventricular (RV) lead for subjects with an ICD device; APCT of atrial lead and VPCTs of right ventricular (RV) and left ventricular (LV) leads for those with a CRT-D device. PCTs of each subject will be measured prior to the 3.0T MRI scan and at the one-month post-MRI. Change in PCT is defined as PCT measured at one-month post-MRI subtracts that measured prior to a 3.0T MRI scan. Proportion of subjects with an increase less than or equal to 0.5V in APCT or VPCTs from pre-MRI to one-month post-MRI will also be used to characterize the efficacy performance of SureScan with respect to PCTs. If the 1-month post-MRI APCT or VPCT is missing, the PCT measured immediately post-MRI will be used instead. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital Southern Medical University | Guangzhou | Guangdong | China | |||
| Affiliated Hospital of Zunyi Medical University |
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Among the 64 enrolled subjects, 1 subject exited the study without having an MRI attempt and 63 subjects underwent an MRI attempt. Of the 63 subjects who had an MRI attempt, 61 completed the 1-month post MRI visit and exited the study afterwards because of study completion, and the other 2 subjects missed the 1-month post MRI visit due to subject withdrawal (1) and femur fracture (1).
The first site was activated on 27 Nov 2023 and the first subject was enrolled on 28 November 2023. The last subject enrollment occurred on 27 August 2024. Sites were notified of enrollment completion on 27 Aug 2024. Sites were instructed to exit subjects starting 17 Oct 2024 to close the study. The last study exit occurred on 28 October 2024. Overall, 64 subjects enrolled at 5 clinical sites in mainland China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Market Released 3.0T Conditional CIED Systems Undergoing 3.0T MRI Scan Attempt | This was a single-arm study 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). Study devices refer to China market released 3.0T Magnetic resonance (MR) conditional CIED systems. Subjects implanted with a SureScan study device who underwent a 3.0T MRI scan attempt were considered in endpoint analyses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Among the 64 enrolled subjects, one subject exited the study before an MRI attempt due to withdrawal by subject; this subject did not have baseline information collected. Therefore, baseline characteristics summarized for the 63 subjects who underwent a 3.0T MRI scan attempt.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Market Released 3.0T Conditional CIED Systems Undergoing 3.0T MRI Scan Attempt | This was a single-arm study 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). Study devices refer to China market released 3.0T Magnetic resonance (MR) conditional CIED systems. Subjects implanted with a SureScan study device who underwent a 3.0T MRI scan attempt were considered in endpoint analyses. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Occurrence of an MRI-related Event for CIED | The primary objective was to demonstrate the safety of SureScan system CIED in clinical 3.0T MRI environment within 1-month post-MRI scan. Specifically, it was hypothesized that the MRI-related event-free rate within 1-month post-MRI to be greater than 90%. The proportion of subjects free from MRI-related events was calculated by dividing the number of subjects without an MRI-related event by the number of subjects at risk for an event. The occurrence of any of the following within 30 days after a 3.0T MRI scan would be considered an MRI-related event: (1) Medical advisor-assessed MRI-related complication within 30 days post-MRI (for iPG, ICD or CRT-D); (2) Medical advisor-assessed right ventricular MRI-related loss of capture within 30 days post-MRI (for iPG, ICD or CRT-D); (3) Sustained tachyarrhythmia originating during SureScan programming, requiring immediate treatment (defined as ATP, device shock, or external shock), as assessed by a medical advisor (for ICD or CRT-D). | Of the 63 patients who underwent an MRI attempt, 4 patients were not qualified for the analysis (including 2 patients for whom device testing was not done at both pre- and post-MRI visits, 1 patient who did not meet pre-MRI requirements and missed 1-month post MRI visit, and 1 patient who missed 1-month post MRI visit). The remaining 59 patients were included in the endpoint analysis for MRI-related events. | Posted | Count of Participants | Participants | The event will be collected within 30 days after MRI visit. |
Adverse events of all the 64 enrolled subjects were collected from enrollment to exit over an average of 178 days of follow-up.
All adverse events (AEs) were collected throughout the study duration, starting at the time the Informed Consent Form was signed. Reporting of these events to Medtronic occurred on an AE form. Each event must be reported separately. Documented pre-existing conditions were not considered as reportable AEs unless the nature or severity of the condition had worsened.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Subjects | All subjects enrolled in the study | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Tang, Principal Clinical Research Specialist | Medtronic | 862138986622 | peter.tang@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2024 | Oct 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| The evaluation will be compared from pre-MRI to 1-month post-MRI scan |
| Zunyi |
| Guizhou |
| China |
| Shanghai Tongren Hospital | Shanghai | Shanghai Municipality | China |
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| New York Heart Association (NYHA) Classification | Count of Participants | Participants | No |
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| Secondary | The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan. | There was no hypothesis for this secondary objective. Pacing capture thresholds (PCTs) to be characterized include: APCT of atrial lead for subjects with an IPG device; APCT of atrial lead and VPCT of right ventricular (RV) lead for subjects with an ICD device; APCT of atrial lead and VPCTs of right ventricular (RV) and left ventricular (LV) leads for those with a CRT-D device. PCTs of each subject will be measured prior to the 3.0T MRI scan and at the one-month post-MRI. Change in PCT is defined as PCT measured at one-month post-MRI subtracts that measured prior to a 3.0T MRI scan. Proportion of subjects with an increase less than or equal to 0.5V in APCT or VPCTs from pre-MRI to one-month post-MRI will also be used to characterize the efficacy performance of SureScan with respect to PCTs. If the 1-month post-MRI APCT or VPCT is missing, the PCT measured immediately post-MRI will be used instead. | The following changes in PCTs were evaluated using descriptive statistics:
| Posted | Mean | Standard Deviation | Volt | The evaluation will be compared from pre-MRI to 1-month post-MRI scan |
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| 64 |
| 5 |
| 64 |
| 0 |
| 64 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and participating institutions will provide any publication of study data generated by the Investigator and/or participating institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
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| Change in PCT of left ventricular lead |
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