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The study was stopped due to challenges with recruitment and insufficient insurance coverage for the required procedures, which prevented continuation of the trial.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patient will receive MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Procedure | MRI with or without contrast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with:
| 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Adverse Events - collected via device monitor after MRI scan. Number of participants with:
|
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep Bansal, MD | The Heart Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancaster General Health | Lancaster | Pennsylvania | 17602 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2020 | Jul 13, 2020 | Prot_000.pdf |
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| 7 years |