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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Kestra Medical Technologies, Inc.
Study ID
NCT05135403
Status
Recruiting
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Conditions

  • Sudden Cardiac Arrest

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Defibrillation — DEVICE
    External defibrillation from a wearable cardioverter defibrillator

Study Details

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.

Key Dates

Start date
Nov 20, 2021
Status verified
Aug 2025
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
5,179 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Overall shock conversion rate [ Time Frame: Up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medical CenterSeattleWashington98033
Kristin Eis, BSChE, MBA
[email protected]
12069636044

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By research site
University of Washington Medical Center· Seattle, WA

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