Adverse Events of MRI With Abandoned Leads

NCT04478773 | Terminated DMC

• 1 other identifier: 2020-43
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pacemaker Electrode Lead Fracture; ICD

Keywords

abandoned lead; fractured lead

Outcome Measures

Primary Outcomes (1)

• 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: 1. Pulling in pocket 2. Chest pain 3. Burning in pocket 4. Palpitations 5. Shortness of breath 6. Other Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with: 1. Atrial fibrillation 2. Ventricular arrhythmias 3. Frequent premature ventricular contractions with hemodynamic instability 4. Symptomatic bradycardia with heart rate less than 40 beats per minute

  2 hours

Secondary Outcomes (1)

• Understand longitudinal utilization and safety of subsequent MRIs

  7 years

Study Arms (1)

Experimental

EXPERIMENTAL

Patient will receive MRI

Procedure: MRI

Interventions

MRI PROCEDURE

MRI with or without contrast

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

Study Officials

• Sandeep Bansal, MD

  The Heart Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 21, 2020
• Study Start: December 2, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)