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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this study is to better understand the following aims:
We propose a registry study in hematopoietic stem cell transplant (HSCT) patients with incident atrial fibrillation/atrial flutter (AF/AFL) during the initial 30 days of transplant who will be implanted with the Medtronic Reveal Linq Implantable Cardiac Monitor (ICM) within 90 days of HSCT. We will evaluate the rate of recurrent AF/AFL as well as incident episodes of major cardiovascular events and the safety of ICM implantation in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hematopoietic Stem Cell Transplant (HSCT) Patients | - Patients with incidence of AF/AFL in the first 30 days of transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSCT Patients | Other | Prospective, observational review of incidence of AF/AFL through Carelink remote monitoring and safety of implantation of device in this population of patients through review of standard of care follow up visits post HSCT implant |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent AF/AFL episodes | Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incident Episodes of Interest | Incident episodes of: stroke/TIA; other thromboembolic events (not stroke/TIA); Heart failure events; ischemic heart events. Overall device implantation safety. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with the diagnosis that requires them to undergo HSCT who develop incident AF/AFL in the first 30 days of transplant.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fradley, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |