The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups

NCT07189728 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Russo_MagnaSafe2
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been published by the Heart Rhythm Society, and the Medicare National Coverage Determination (NCD) has been modified to provide coverage for these patients (CAG-00399R4). However, for patients with an abandoned, epicardial, or fractured cardiac lead or subcutaneous array, with a "mixed-vendor" or same-vendor "mixed-component" CIED, or those undergoing MRI at 3.0-tesla with a device not labelled as MRI-conditional (MRC) for use at 3-tesla, the risks of MRI have not been determined. Hypothesis: For patients with an MRC or NMRC pacemaker or defibrillator and specific indications or circumstances not presently addressed, the risks of MRI do not increase. Purpose: The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI. Study Design: A prospective registry of patients undergoing clinically indicated MRI. The protocol is being developed in collaboration with the FDA's Center for Devices and Radiological Health, and an Investigational Device Exemption is being requested for event reporting and monitoring. Also, "Coverage with Evidence Development (CED)" has been requested from CMS. Enrollment: Eligible patients are 18 years or older and have a MRC or NMRC pacemaker system from any manufacturer, (after 2001), with leads from any manufacturer (without date restriction), and if the ordering physician has determined that MRI is clinically indicated, the imaging method of choice, and NOT performed for the purpose of research. Exclusions are a leadless pacemaker, a device battery at "elective replacement indicator," or renal insufficiency (GFR \<45 cc/min). All participants will be required to provide informed consent for the collection of data. Methods: Patients will be enrolled in the registry at up to 30 clinical centers with: (1) an NMRC pacing system scheduled for MRI at a magnet field strength of 3-tesla, (2) an NMRC system due to a "mixed-vendor" or a same vendor "mixed-component" platform at 1.5-tesla or 3-tesla, or (3) an MRC or NMRC pacing system and an abandoned, epicardial, or fractured lead at 1.5-tesla. Primary Endpoints: A new cardiac arrhythmia noted during the MRI scan, or a Troponin-T elevation (\>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI. Secondary Endpoints: Death, generator or lead failure requiring immediate replacement, loss of pacing capture (pacing-dependent patients), partial or full generator-electrical reset, pacing lead threshold increase of ≥1.0 V, a P-wave amplitude decrease of ≥50%, an R-wave amplitude decrease of ≥50%, and a pacing lead impedance change of ≥50 ohms from baseline. Sample Size: Using an event rate limit of ≤1%, 500 cases will be needed in each group to yield a 95% confidence interval of 0 to 1.0% if no events are observed. When a total of 500 cases have been enrolled in one group, enrollment in the other groups may be continued at the discretion of the investigators. The estimated study duration is 5 years, including enrollment and data analysis. Clinical Implications and Impact: The anticipated results will support an amendment to the current HRS Expert Consensus Statement (2017) and Medicare NCD (April 2018) for the patient groups in the study.

Conditions

Pacemakers; MRI Imaging; Implantable Cardioverter Defibrillator (ICD)

Keywords

pacemaker; MRI; implantable cardioverter defibrillator; abandoned cardiac leads; 3-tesla

Outcome Measures

Primary Outcomes (1)

• Troponin T levels

  Troponin-T elevation (\>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI.

  Baseline and 24 hours

Secondary Outcomes (6)

• Arrythmia

  Periprocedural

• Changes to pacemaker

  Periprocedural

• Heart function

  Periprocedural

• Heart function

  Periprocedural

• Changes to pacemaker

  Periprocedural

Interventions

MRI DIAGNOSTIC_TEST

The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The proposed study, the MagnaSafe-2 Registry, is a prospective, multicenter registry designed to determine the risks of MRI in three groups of patients presently without access to clinically indicated MRI and not previously addressed in clinical investigations or peer-reviewed literature. The three groups of patients presently without adequate access to MRI are those with (1) a patient with CIED system scheduled for MRI at a magnet field strength of 3-tesla and labelled NMRC at that field strength, (2) a patient with an NMRC system due to a "mixed-vendor" or a same vendor "mixed-component" system scheduled for imaging at 1.5-tesla or 3-tesla, and (3) a patient with an MRC or NMRC pacing system and an abandoned lead, epicardial lead, fractured lead or subcutaneous array scheduled for clinically indicated MRI at a field strength of 1.5-tesla.

You may qualify if:

• Patients will be included in the registry if they fulfill all the following criteria:
• Age of 18 years or older
• Able to provide informed consent for entry in the research registry
• Have a CIED from any manufacturer implanted after 2001
• Have cardiac leads from any manufacturer without an implant date limitation
• Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology
• The patient is scheduled for that imaging procedure
• MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol
• In addition, groups within the protocol require that an enrolled patient will have:
• An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength.
• A "mixed-vendor" or same vendor "mixed-component" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment.
• A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array.

You may not qualify if:

• Patients will not be included in the registry if they fulfill any of the following criteria:
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• A generator battery at the elective replacement indicator (ERI)
• Renal insufficiency (GFR \<45 cc/min)

Sponsors & Collaborators

• The Scripps Research Institute: lead

Related Publications (1)

• Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265.

  PMID: 28225684 BACKGROUND

Related Links

• Lab website

Study Officials

• Robert J Russo, MD, PhD

  Scripps Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert J Russo

CONTACT

8587842211; russo@scripps.edu

Nicola Mair

CONTACT

18587842211; nmair@scripps.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be stored and will remain available to appropriate investigators for 5 years following study publication following collection and locking of the database.
• Access Criteria: Access to study data will be considered upon request to the coordinating center. NHLBI BioData Catalyst, a cloud-based system offering access in a secure workspace, will be utilized. Using this access portal, NHLBI-funded research/data may be reproduced by others to advance their scientific endeavors. When the results of the study are available, a manuscript will be submitted to the appropriate medical journal to achieve the best dissemination of the study results and conclusions. After the study, the results will be presented at either the annual scientific sessions of the American Heart Association and/or the American College of Cardiology. In addition, when the results of the study are available, results and conclusions will be posted at ClinicalTrial.gov.