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Procedure

MRI Safety for Pacemaker Lead Fracture

N/A

Waitlist Available

Led By Sandeep Bansal, MD

Research Sponsored by Lancaster General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

Study Summary

This trial will help researchers learn if MRI scanning is safe and effective for patients with broken or abandoned heart implants, and if it impacts their care.

Who is the study for?

This trial is for English or Spanish speaking adults with a broken or unused heart device lead who need an MRI scan. It's not for those unsuitable for MRI due to other reasons, or anyone under 18.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of MRI scans in patients with fractured or abandoned leads from pacemakers or defibrillators, aiming to influence Medicare/Medicaid coverage decisions.See study design

What are the potential side effects?

While not drug-related, potential side effects may include discomfort during the MRI procedure, anxiety from being in a confined space, and heating at the lead site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a heart device and need an MRI despite having a non-working lead.

Select...

I can speak and understand English or Spanish and can sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Secondary outcome measures

Magnetic Resonance Imaging, Cine

Trial Design

1Treatment groups

Experimental Treatment

Group I: ExperimentalExperimental Treatment1 Intervention

Patient will receive MRI

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~1370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lancaster General HospitalLead Sponsor

22 Previous Clinical Trials

3,774 Total Patients Enrolled

Sandeep Bansal, MDPrincipal InvestigatorThe Heart Group

1 Previous Clinical Trials

262 Total Patients Enrolled

Media Library

MRI (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04478773 — N/A

Pacemaker Lead Fracture Research Study Groups: Experimental

Pacemaker Lead Fracture Clinical Trial 2023: MRI Highlights & Side Effects. Trial Name: NCT04478773 — N/A

MRI (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04478773 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research trial open at the moment?

"As indicated on clinicaltrials.gov, this medical trial is actively searching for enrollees; the initial posting date being December 2nd 2020 and a recent amendment taking place September 29th 2022."

Answered by AI

How many participants are being recruited for this trial?

"Affirmative. Research posted on clinicaltrials.gov affirms that recruitment for this medical trial, which was initially shared on December 2nd 2020, is ongoing. For the project to succeed, 60 individuals need to be enlisted from a single testing site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adverse Events of MRI With Abandoned Leads

2020. "Adverse Events of MRI With Abandoned Leads". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04478773.