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The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NYHA class III or IV | Patients with NYHA class III or IV during the past month and one or more of the following:
|
| |
| left ventricular ejection fraction ≤ 35% | Patients with left ventricular ejection fraction ≤ 35% and either one of the following:
|
| |
| Awaiting ICD re-implantation |
| ||
| Acute myocardial infarction | Patients hospitalized with acute myocardial infarction and Killip Class III/IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearable defibrillator (LifeVest) | Device | LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation |
| Measure | Description | Time Frame |
|---|---|---|
| Defibrillation for life-threatening ventricular tachyarrhythmias | 6 months | |
| Assess magnitude and complexity of ventricular and atrial arrhythmias during use | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total mortality | 6 months and 12 months | |
| Compliance with wearable defibrillator use | 6 months | |
| Quality of life with a wearable defibrillator |
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Inclusion Criteria:
Patients with NYHA class III or IV during the past month and one or more of the following:
Patients with left ventricular ejection fraction ≤ 35% and either one of the following:
Patients awaiting ICD re-implantation following device explantation or lead extraction,
Patients hospitalized with acute myocardial infarction and Killip Class III/IV.
Exclusion Criteria:
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patients with left ventricular dysfunction or advanced heart failure symptoms (New York Heart Association functional Class III/IV), who have a high-risk for sudden cardiac death, but are not eligible for an implantable defibrillator or are not able to receive one due to their condition.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Eldar, MD | Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14627 | United States | ||
| Chaim Sheba Medical Center |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D003645 | Death, Sudden |
| D016757 | Death, Sudden, Cardiac |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
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|
| 6 months |
| Complications (adverse events) with wearable defibrillator use | 6 months |
| Tel Litwinsky |
| 52621 |
| Israel |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |