Trial results for a study investigating the safety of SureScan CIEDs in a 3.0T MRI environment for patients with Heart Failure, Bradycardia, and Tachycardia were posted on 2026-01-14. The study reported 0 MRI-related events for CIEDs among 59 participants who completed 3.0T MRI scans and 1-month post-MRI follow-up.
Background
Patients with cardiac conditions such as heart failure, bradycardia, and tachycardia often rely on Cardiac Implantable Electronic Devices (CIEDs) for managing their heart rhythms. Historically, magnetic resonance imaging (MRI) scans have posed a challenge for patients with CIEDs due to potential interactions between the strong magnetic fields and the device, which could lead to device malfunction or patient harm. This has limited diagnostic options for many patients. The development of MRI-conditional CIEDs, like those with SureScan technology, aims to allow patients to safely undergo MRI scans, thereby expanding their diagnostic and treatment options.
Trial design
This completed study, identified as Phase NA, enrolled 64 participants. The trial focused on confirming the safety of SureScan CIEDs in a clinical 3.0T MRI environment. Participants had conditions including Bradycardia, Tachycardia, and Heart Failure. All subjects underwent required follow-up visits at baseline, MRI visit, and 1-month post-MRI. The MRI scan region was determined by the investigator based on the subject's clinical condition.
Key results
The trial evaluated the occurrence of MRI-related events for CIEDs and changes in pacing capture thresholds.
- For the outcome "The Occurrence of an MRI-related Event for CIED," among the 59 subjects with a SureScan study device completing a 3.0T MRI scan and 1-month post-MRI follow-up, 0 participants experienced an MRI-related event.
- An analysis using a one-proportion binomial exact test showed an MRI-related event-free rate of 100.0%. The one-sided 97.5% lower confidence bound was 93.94%, with a p-value of 0.002. This result rejected the null hypothesis that the event-free rate was less than or equal to 90%.
- Regarding "The Changes in Atrial and Ventricular Pacing Capture Thresholds From Pre-MRI to 1-month Post-MRI Scan," the mean changes observed were -0.04 Volt (Standard Deviation: 0.17), 0.02 Volt (Standard Deviation: 0.20), and 0.14 Volt (Standard Deviation: 0.42) for subjects undergoing a 3.0T MRI scan attempt.
What this means
The results of this study suggest that SureScan CIEDs can be safely used in a 3.0T MRI environment for patients with conditions such as heart failure, bradycardia, and tachycardia. The finding of 0 MRI-related events among 59 participants, coupled with a 100.0% event-free rate and a lower confidence bound exceeding 90%, provides strong evidence for the safety profile of these devices under the tested conditions. The minimal changes observed in atrial and ventricular pacing capture thresholds further support the stability of device function post-MRI. This is a significant development for patients who may require advanced diagnostic imaging like 3.0T MRI but have previously been limited due to their cardiac implants, potentially improving their access to comprehensive medical care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06038123, titled "China 3T MRI Study", were posted on 2026-01-14 on clinicaltrials.gov.