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

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Arrest
• Intervention / Treatment: Device: Defibrillation

• Study Type: Observational
• Enrollment (Estimated): 5179

Contacts and Locations

• Study Contact: Name: Ron Rowbotham, MSEE, CCRA; Phone Number: 14255264913; Email: ron.rowbotham@kestramedical.com

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98033
      • Recruiting
      • University of Washington Medical Center
      • Contact: RON ROWBOTHAM; Phone Number: 206-816-5701; Email: RKROWBOTHAM@MSN.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Defibrillation; External defibrillation from a wearable cardioverter defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall shock conversion rate	Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%	Up to 3 years
Inappropriate shocks per patient month	Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First shock conversion rate	Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only)	Up to 3 years
Inappropriate shock rate	Percent of patients who experience at least one inappropriate shock (report only)	Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate shock rate per month	Number of appropriate shocks/cumulative months of WCD use	Up to 3 years
Appropriate shock rate	Percent of patients who experience at least one appropriate shock	Up to 3 years
Total Shocks delivered	Number of shocks delivered	Up to 3 years
Shocks diverted	Number of shocks diverted by patients	Up to 3 years
False positive shock alarm rate	Number of false positive shock alarms/cumulative WCD use	Up to 3 years
True positive shock alarm rate	Number of true positive shock alarms/cumulative WCD use	Up to 3 years
Adverse events	Adverse events related to use of the WCD	Up to 3 years
Average daily device use	Average daily use of the WCD in hours per day	Up to 3 years
Cumulative device use	Cumulative device use in days	Up to 3 years

Collaborators and Investigators

• Sponsor: Kestra Medical Technologies, Inc.
• Investigators: Principal Investigator: Jeanne Poole, M.D., University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: DHF-00187-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No