The Scripps Research Institute has initiated plans for a new clinical trial titled ‘The MagnaSafe-2 Registry,’ focusing on evaluating the safety and potential risks of undergoing MRI imaging in patients with pacemakers and Implantable Cardioverter Defibrillators (ICDs). This trial addresses a critical gap in understanding the diagnostic safety of MRIs for these three distinct patient groups.
What is MagnaSafe-2 Registry?
The MagnaSafe-2 Registry aims to build upon prior research conducted on patients with magnetic resonance imaging (MRI) safety concerns due to cardiac implantable electronic devices (CIEDs). Pacemakers and ICDs have historically been flagged as potential risk factors during MRI procedures due to interactions with the magnetic environment and device components. This registry is being sponsored by The Scripps Research Institute and remains listed as ‘Not yet recruiting’ as of October 5, 2025.
The primary intervention within the trial will be MRI imaging as a diagnostic test under close clinical observation, ensuring detailed data is collected pre and post-procedure.
Why study MRI risks in device patients?
Magnetic resonance imaging (MRI) has long been considered one of the most effective diagnostic tests for visualizing soft tissue anomalies. However, for individuals with pacemakers or ICDs, MRIs pose unique risks such as thermal heating, electromagnetic interference with device circuitry, or disruption of programmed functionalities. The MagnaSafe-2 Registry seeks to fill knowledge gaps concerning how these risks manifest in different patient profiles and device types.
Scope of Concern
Patients with legacy CIED models remain an underserved area of study for MRI safety compared to modern resin-coated device designs. This registry trial will systematically examine legacy devices as well as recently implanted technological models to evaluate outcomes in real clinical contexts.
What does the trial involve?
The study is structured as a diagnostic intervention with MRI imaging protocols uniquely tailored to the needs of pacemaker and ICD users. Participants will undergo MRIs under controlled and observed conditions, with planned monitoring that measures device safety parameters, physiological reactions, and antenna-related responses.
Key Trial Objectives
- Document device behavior under MRI settings.
- Assess safety protocols needed to prevent device malfunction.
- Provide evidence-based safety recommendations for clinical practitioners.
Stakeholders Who Should Monitor Updates
Regulatory specialists, clinical trial management teams, and medical device manufacturers are encouraged to stay informed about updates to recruitment status and trial results. Meta-analysis of registry findings could influence regulatory policies and device labeling requirements in the area of diagnostic imaging safety.
Frequently Asked Questions
- Who conducts the MagnaSafe-2 Registry? The trial is sponsored by The Scripps Research Institute.
- Are patients recruited yet? As of October 5, 2025, the trial is listed as ‘Not yet recruiting.’
- What devices are studied? Pacemakers and Implantable Cardioverter Defibrillators (ICDs).
- What is the intervention? The primary intervention is MRI diagnostic imaging.
Clinical and Regulatory Implications
The MagnaSafe-2 Registry holds promise for advancing understanding of MRI compatibility among patients with cardiac implantable electronic devices. Insights from this study may shape future clinical guidelines, industry protocols, and regulatory frameworks surrounding MRI practices for device patients.
Disclaimer
This content is provided for informational purposes only and should not be taken as clinical or legal advice. Professionals should consult authoritative sources and regulatory bodies for compliance guidance.
Full Announcement Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07189728?term=medical+device