Bradycardia, Heart Failure, Tachycardia
Conditions
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. 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.
Interventions
DEVICEChina market released 3.0T Magnetic resonance (MR) conditional CIED systems
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)
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Occurrence of an MRI-related Event for CIED | The event will be collected within 30 days after MRI visit. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan. | The evaluation will be compared 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. |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | not return due to femur fracture | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Subjects With Market Released 3.0T Conditional CIED Systems Undergoing 3.0T MRI Scan Attempt | — |
|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 10.8 | — |
| New York Heart Association (NYHA) Classification Class III (Moderate): Marked limitation of activity | 15 Participants | — |
| New York Heart Association (NYHA) Classification Class II (Mild): Slight limitation of activity | 21 Participants | — |
| New York Heart Association (NYHA) Classification Class I (Mild): No symptoms with ordinary physical activity; no limitation of activity. | 2 Participants | — |
| New York Heart Association (NYHA) Classification Class IV (Severe): Inability to carry on any physical activity without discomfort | 0 Participants | — |
| New York Heart Association (NYHA) Classification Subject does not have heart failure | 25 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 39 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 64 |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 5 / 64 |
Outcome results
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).
Time frame: The event will be collected within 30 days after MRI visit.
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit | The Occurrence of an MRI-related Event for CIED | Without MRI-related events within 1-month post MRI visit | 59 Participants |
| Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit | The Occurrence of an MRI-related Event for CIED | With MRI-related events within 1-month post MRI | 0 Participants |
Comparison: Alternative hypothesis: MRI-related event-free rate within 1-month post-MRI \>90%. Null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is \>90%. Assuming type I error rate of 0.025, even-free rate under null hypothesis being 90% and true even-free rate being 99.5%, the minimum required sample size is 54 MRI scanned patients to achieve 90% power. One-proportion binomial exact test along with a one-sided 97.5% lower (Clopper-Pearson) confidence bound was used.p-value: 0.002One-proportion binomial exact test
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.
Time frame: The evaluation will be compared from pre-MRI to 1-month post-MRI scan
Population: The following changes in PCTs were evaluated using descriptive statistics:~* Right atrial lead measured in 45 patients, attrition: device testing not done (2) , no exiting lead (11), unable to lose capture (1), pre-MRI requirements not met/missing (4).~* Right ventricular lead measured in 60 patients, attrition: device testing not done (2), pre-MRI requirements not met (1).~* Left ventricular lead measured in 9 patients, attrition: device testing not done (2), no existing lead (n=52).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit | The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan. | Change in PCT of right atrial lead | -0.04 Volt | Standard Deviation 0.17 |
| Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit | The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan. | Change in PCT of right ventricular lead | 0.02 Volt | Standard Deviation 0.2 |
| Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit | The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan. | Change in PCT of left ventricular lead | 0.14 Volt | Standard Deviation 0.42 |