Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASSURE Registry Patients | Patient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillation | Device | External defibrillation from a wearable cardioverter defibrillator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall shock conversion rate | Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0% | Up to 3 years |
| Inappropriate shocks per patient month | Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075 | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| First shock conversion rate | Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only) | Up to 3 years |
| Inappropriate shock rate |
| Measure | Description | Time Frame |
|---|---|---|
| Appropriate shock rate per month | Number of appropriate shocks/cumulative months of WCD use | Up to 3 years |
| Appropriate shock rate | Percent of patients who experience at least one appropriate shock |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Eis, BSChE, MBA | Contact | 14256547596 | kristin.eis@kestramedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeanne Poole, M.D. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98033 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
Not provided
Not provided
| ID | Term |
|---|---|
| D004554 | Electric Countershock |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Percent of patients who experience at least one inappropriate shock (report only)
| Up to 3 years |
| Up to 3 years |
| Total Shocks delivered | Number of shocks delivered | Up to 3 years |
| Shocks diverted | Number of shocks diverted by patients | Up to 3 years |
| False positive shock alarm rate | Number of false positive shock alarms/cumulative WCD use | Up to 3 years |
| True positive shock alarm rate | Number of true positive shock alarms/cumulative WCD use | Up to 3 years |
| Adverse events | Adverse events related to use of the WCD | Up to 3 years |
| Average daily device use | Average daily use of the WCD in hours per day | Up to 3 years |
| Cumulative device use | Cumulative device use in days | Up to 3 years |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |