ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

Kestra Medical Technologies

Status: Enrolling

Conditions: Sudden Cardiac Arrest

Treatments: Device: Defibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT05135403

DHF-00187-01

Details and patient eligibility

About

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.

Enrollment: 5,179 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,179 participants in 1 patient group

ASSURE Registry Patients

Description:

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.

Treatment:

Device: Defibrillation