Adverse Events of MRI With Abandoned Leads

Not Applicable

Active, not recruiting

• Conditions: Pacemaker Electrode Lead Fracture; ICD
• Interventions: Procedure: MRI

• Registration Number: NCT04478773
• Lead Sponsor: Lancaster General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-21
• Study Start: 2020-12-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2027-12-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	MRI	Patient will receive MRI

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads	2 hours	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

Secondary Outcome Measures

Name	Time	Method
Understand longitudinal utilization and safety of subsequent MRIs	7 years	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: 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. Number 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

Trial Locations

Locations (1)

Lancaster General Health; 🇺🇸 Lancaster, Pennsylvania, United States