Adverse Events of MRI With Abandoned Leads

ICD Clinical Trial

Official title:

Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04478773
• Other study ID #: 2020-43
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: March 1, 2028

Study information

• Verified date: February 2024
• Source: Lancaster General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: March 1, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ICD
• Pacemaker Electrode Lead Fracture

Intervention

Procedure:
• MRI
MRI with or without contrast

Locations

Country	Name	City	State
United States	Lancaster General Health	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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