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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The investigators seek to conduct a prospective study to assess the recurrence of AF in patients with acute AF using a long-term ECG monitoring strategy with an insertable cardiac monitor (ICM), which is clinically indicated in this scenario as part of the standard of care. The investigators hypothesize that patients diagnosed with acute AF in the setting of cardiac surgery will have higher rates of AF recurrence than acute AF diagnosed in the setting of non-cardiac surgery or medical illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILR |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first documented event of AF by 12 months | The primary objective is to determine the time to first documented event of AF by 12 months of continuous rhythm monitoring, stratified by the setting of acute AF diagnosis (cardiac surgery, non-cardiac surgery, and medical illness). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first documented AF by 6 months | 6 months | |
| Time to first documented AF episode lasting ≥ 5 minutes | 12 months | |
| Mean AF burden |
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Inclusion Criteria:
Patient has an existing clinical indication for implantation of an insertable cardiac monitor (ICM) and will undergo ICM implantation as part of their standard medical care.
Patient is scheduled to receive or has received a Boston Scientific LUX-DXâ„¢ insertable cardiac monitor.
Episode of acute AF. Acute AF is defined as AF detected in an acute care setting or during an acute illness. Before enrollment, the following tests are minimally required as standard tests to establish the diagnosis of acute AF:
Patient or legally authorized representative signs and dates the patient consent form.
Patient is ≥18 years old.
Patient is willing and able to comply with all study procedures and attend the required follow-up visits for the duration of the study.
Exclusion Criteria:
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The selection of participants for this study will be equitable, and no specific populations will be excluded without a clear and compelling rationale related to the health of the participants or the purpose of the research. Limited English proficiency will not be an exclusion criterion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin U Hoffman, MD, PhD | Contact | 858-246-2016 | b2hoffman@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sulpizio Cardiovascular Center | Recruiting | La Jolla | California | 92037 | United States |
In general, de-identified data may be shared with other researchers for scientific purposes, subject to IRB approval and any data sharing agreements. Any such sharing will not include information that could reasonably identify individual participants. No plans to publish participant family pedigrees are anticipated for this study.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 12 months |
| Mean AF episode length | 12 months |
| Change in use of oral anticoagulation and antiarrhythmic drugs | 12 months |
| Quality of life scores (SF-36) | Change in Quality of Life scores as assessed by the Short Form 36 Health Survey (SF-36). The SF-36 is a 36-item, patient-reported survey assessing patient health across eight domains. The scores are weighted and summed to produce a value ranging from 0 to 100, where higher scores indicate a better quality of life (better health outcome). | 12 months |
| Incidence of hospitalization | 12 months |
| Change in medication use | 12 months |
| Incidence of stroke | 12 months |
| Incidence of death | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |