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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-20

Study Completion Date

2025-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Sudden Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Defibrillation

Intervention Type DEVICE

External defibrillation from a wearable cardioverter defibrillator

Interventions

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Defibrillation

External defibrillation from a wearable cardioverter defibrillator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patient prescribed the ASSURE wearable cardioverter defibrillator
* Provided written informed consent to participate in the ASSURE Patient Registry

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No