Trial Outcomes & Findings for China 3T MRI Study (NCT NCT06038123)

Last Updated: 2026-01-14

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

The event will be collected within 30 days after MRI visit.

Results posted on

2026-01-14

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	63
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1
Overall Study not return due to femur fracture	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Market Released 3.0T Conditional CIED Systems Undergoing 3.0T MRI Scan Attempt n=63 Participants 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.
Age, Continuous	65.8 years STANDARD_DEVIATION 10.8 • n=63 Participants
Sex: Female, Male Female	24 Participants n=63 Participants
Sex: Female, Male Male	39 Participants n=63 Participants
New York Heart Association (NYHA) Classification Class I (Mild): No symptoms with ordinary physical activity; no limitation of activity.	2 Participants n=63 Participants
New York Heart Association (NYHA) Classification Class II (Mild): Slight limitation of activity	21 Participants n=63 Participants
New York Heart Association (NYHA) Classification Class III (Moderate): Marked limitation of activity	15 Participants n=63 Participants
New York Heart Association (NYHA) Classification Class IV (Severe): Inability to carry on any physical activity without discomfort	0 Participants n=63 Participants
New York Heart Association (NYHA) Classification Subject does not have heart failure	25 Participants n=63 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit n=59 Participants All subjects implanted with a SureScan study device who have a 3.0T MRI scan after enrollment and have completed their one-month post-MRI scan follow-up, or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the main analysis for the primary objective.
The Occurrence of an MRI-related Event for CIED Without MRI-related events within 1-month post MRI visit	59 Participants
The Occurrence of an MRI-related Event for CIED With MRI-related events within 1-month post MRI	0 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Subjects With a SureScan Study Device Completing 3.0T MRI Scan and 1-month Post MRI Follow-up Visit n=63 Participants All subjects implanted with a SureScan study device who have a 3.0T MRI scan after enrollment and have completed their one-month post-MRI scan follow-up, or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the main analysis for the primary objective.
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
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 0.20
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

Adverse Events

Enrolled Subjects

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enrolled Subjects n=64 participants at risk All subjects enrolled in the study
Cardiac disorders Cardiac failure acute	1.6% 1/64 • Number of events 1 • 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.
Injury, poisoning and procedural complications Femur fracture	1.6% 1/64 • Number of events 1 • 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.
Nervous system disorders Syncope	1.6% 1/64 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/64 • Number of events 1 • 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.
Vascular disorders Orthostatic hypotension	1.6% 1/64 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Peter Tang, Principal Clinical Research Specialist

Medtronic

Phone: 862138986622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER