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Enrollment
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This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wearable defibrillator use | subjects will use a wearable defibrillator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearable defibrillator (LifeVest) | Device | A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients who experience sudden cardiac death | three months |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients who experience inappropriate shocks | three months | |
| hours per day of wearable defibrillator use | three months | |
| number of patients who experience sudden cardiac arrest |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Szymkiewicz, MD | Zoll Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Heart and Vascular Institute | Sacramento | California | 95819 | United States | ||
| Saint Joseph's Health System, Inc. |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D014693 | Ventricular Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D018754 | Ventricular Dysfunction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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|
| three months |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Texas Heart Institute, St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Chippenham Johnston-Willis Medical Center | Richmond | Virginia | 23225 | United States |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D014652 | Vascular Diseases |