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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKestra Medical Technologies, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Adult patient prescribed the ASSURE wearable cardioverter defibrillator

Provided written informed consent to participate in the ASSURE Patient Registry

Disqualifiers

Patients who do not meet the Inclusion criteria

Trial design

Treatments tested in this trial

  • Defibrillation

Treatment groups

5,179 Participants
are divided into 1 treatment group