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Recruiting NCT05135403

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

— Observational Sudden Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Defibrillation.
Who it may be relevant to
Registry conditions: Sudden Cardiac Arrest. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Defibrillation
    External defibrillation from a wearable cardioverter defibrillator

Primary outcome measures

  • Overall shock conversion rate [Time frame: Up to 3 years]
  • Inappropriate shocks per patient month [Time frame: Up to 3 years]
Secondary outcome measures (2)
  • First shock conversion rate [Time frame: Up to 3 years]
  • Inappropriate shock rate [Time frame: Up to 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Washington Medical Center — Seattle

Identifiers

NCT: NCT05135403 · DHF-00187-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗