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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart device and need an MRI despite having a non-working lead.I am under 18 years old.I can speak and understand English or Spanish and can sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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