Pacemaker Electrode Lead FractureNCT04478773
Adverse Events of MRI With Abandoned Leads
A study testing MRI in people with Pacemaker Electrode Lead Fracture and ICD, run by Lancaster General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pacemaker Electrode Lead Fracture, ICD
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Health
Lancaster, Pennsylvania, 17602
About this study
Official title: Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads
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.
- Conditions
- Pacemaker Electrode Lead Fracture, ICD
- Being tested
- MRI
- Keywords
- abandoned lead, fractured lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI with or without contrast
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patient will receive MRI Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (1)
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
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start2 Dec 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: The study was stopped due to challenges with recruitment and insufficient insurance coverage for the required procedures, which prevented continuation of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker Electrode Lead FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandeep Bansal, MD, Principal investigator, The Heart Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478773
- Sponsor's protocol ID
- 2020-43
- Status last verified
- Sep 2025
- First submitted
- 13 Jul 2020
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads
- ClinicalTrials.gov ID
- NCT04478773
- Acronym / sponsor ID
- 2020-43
- Conditions
- Pacemaker Electrode Lead Fracture, ICD
- Keywords
- abandoned lead, fractured lead
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to challenges with recruitment and insufficient insurance coverage for the required procedures, which prevented continuation of the trial.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: MRIPatient will receive MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI with or without contrast | Procedure or surgery | Experimental |
Primary outcome
Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads
Time frame: 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
1 secondary outcome
Understand longitudinal utilization and safety of subsequent MRIs
Time frame: 7 years
Results and safety
The study was stopped early (reason given: The study was stopped due to challenges with recruitment and insufficient insurance coverage for the required procedures, which prevented continuation of the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Bansal, MD principal investigator
The Heart Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Pacemaker Electrode Lead Fracture and ICD, run by Lancaster General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to challenges with recruitment and insufficient insurance coverage for the required procedures, which prevented continuation of the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.