ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Purpose
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.
Condition
- Sudden Cardiac Arrest
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult patient prescribed the ASSURE wearable cardioverter defibrillator - Provided written informed consent to participate in the ASSURE Patient Registry
Exclusion Criteria
- Patients who do not meet the Inclusion criteria
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
University of Washington Medical Center
Seattle, Washington 98033
Seattle, Washington 98033
More Details
- NCT ID
- NCT05135403
- Status
- Recruiting
- Sponsor
- Kestra Medical Technologies, Inc.