Adverse Events of MRI With Abandoned Leads

Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads

The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide community-acquired data that can be used in Medicare and Medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an MRI and to evaluate the impact of MRI availability on patient care in this population. This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient population.

Study Overview

• Status: Terminated
• Conditions: ICD; Pacemaker Electrode Lead Fracture
• Intervention / Treatment: Procedure: MRI

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Patients implanted with or without an ICD or pacemaker and with a fractured or an abandoned or non-functional endocardial lead, and who have a clinical need for MR imaging
• Patients are English or Spanish speaking and able to review and sign the consent

Exclusion criteria:

• Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason other than abandoned or fractured endocardial, or epicardial lead.
• Patients less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Patient will receive MRI	Procedure: MRI; MRI with or without contrast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads	Incidence of symptoms and adverse events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads. The following measures will be collected twice during the MRI scan and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider. Proportion/percentage of participants with: Pulling in pocket; Chest pain; Burning in pocket; Palpitations; Shortness of breath; Other Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with: Atrial fibrillation; Ventricular arrhythmias; Frequent premature ventricular contractions with hemodynamic instability; Symptomatic bradycardia with heart rate less than 40 beats per minute	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understand longitudinal utilization and safety of subsequent MRIs	The second component of the study allows subjects to re-enroll for subsequent MRI scans as ordered by their physician to understand utilization and safety. The following measures will be collected and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider : Patient Reported Symptoms - collected twice during the MRI scan. Number of participants with a subsequent MRI that experience: pulling in pocket; chest pain; burning in pocket; palpitations; shortness of breath; Other Adverse Events - collected via device monitor after MRI scan. Number of participants with: atrial fibrillation; ventricular arrhythmias; frequent premature ventricular contractions with hemodynamic instability; symptomatic bradycardia with heart rate less than 40 beats per minute	7 years

Collaborators and Investigators

• Sponsor: Lancaster General Hospital
• Investigators: Principal Investigator: Sandeep Bansal, MD, The Heart Group

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: abandoned lead; fractured lead
• Other Study ID Numbers: 2020-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No