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NCT Number: NCT05135403

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

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.

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Key information

Conditions

Sudden Cardiac Arrest Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington Medical Center

Seattle, Washington, 98033, United States

Location status: Recruiting

Location contact

Kristin Eis, BSChE, MBA

CONTACT

[email protected]

12069636044

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Defibrillation

Device

External defibrillation from a wearable cardioverter defibrillator

Primary outcomes

  1. Overall shock conversion rate

    Time frame: Up to 3 years

    Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%

  2. Inappropriate shocks per patient month

    Time frame: Up to 3 years

    Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075

Secondary outcomes

  1. First shock conversion rate

    Time frame: Up to 3 years

    Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only)

  2. Inappropriate shock rate

    Time frame: Up to 3 years

    Percent of patients who experience at least one inappropriate shock (report only)

Other outcomes

  1. Appropriate shock rate per month

    Time frame: Up to 3 years

    Number of appropriate shocks/cumulative months of WCD use

  2. Appropriate shock rate

    Time frame: Up to 3 years

    Percent of patients who experience at least one appropriate shock

  3. Total Shocks delivered

    Time frame: Up to 3 years

    Number of shocks delivered

  4. Shocks diverted

    Time frame: Up to 3 years

    Number of shocks diverted by patients

  5. False positive shock alarm rate

    Time frame: Up to 3 years

    Number of false positive shock alarms/cumulative WCD use

  6. True positive shock alarm rate

    Time frame: Up to 3 years

    Number of true positive shock alarms/cumulative WCD use

  7. Adverse events

    Time frame: Up to 3 years

    Adverse events related to use of the WCD

  8. Average daily device use

    Time frame: Up to 3 years

    Average daily use of the WCD in hours per day

  9. Cumulative device use

    Time frame: Up to 3 years

    Cumulative device use in days

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Eis, BSChE, MBA

CONTACT

[email protected]

14256547596

Sponsors and collaborators

Lead sponsor

Kestra Medical Technologies, Inc.

Industry

Registry information

Acronym: ACE-PAS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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