Adverse Events of MRI With Abandoned Leads

Sponsor

Lancaster General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04478773

Collaborator

(none)

Enrollment

Location

Arm

26.9

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker Electrode Lead Fracture ICD	Procedure: MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads

Actual Study Start Date :

Dec 2, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental

Patient will receive MRI

Procedure: MRI

MRI with or without contrast

Outcome Measures

Primary Outcome Measures

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]
Determine the incidence of adverse events during MRIs in patients with abandoned or fractured leads who have a clinical need for MRI via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider. Adverse events include but are not limited to: Atrial fibrillation Ventricular arrhythmias Frequent premature ventricular contractions with hemodynamic instability Symptomatic bradycardia with heart rate less than 40 beats per minute Shortness of breath Chest pain Feeling of heat/pulling in the chest or device pocket

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion:

Patients implanted with an ICD or pacemaker with 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:

Patients who meet current Centers for Medicare & Medicaid Services(CMS) approved indications for MRI with cardiac implanted electronic device
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lancaster General Health	Lancaster	Pennsylvania	United States	17602

Sponsors and Collaborators

Lancaster General Hospital

Investigators

Principal Investigator: Sandeep Bansal, MD, The Heart Group

Study Documents (Full-Text)

Study Protocol - Jun 9, 2020

More Information

Publications

None provided.

Responsible Party:

Lancaster General Hospital

ClinicalTrials.gov Identifier:

NCT04478773

Other Study ID Numbers:

2020-43

First Posted:

Jul 21, 2020

Last Update Posted:

Dec 14, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Lancaster General Hospital

abandoned lead

fractured lead

Study Results

No Results Posted as of Dec 14, 2021