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

Sudden Cardiac Arrest Clinical Trial

— ACE-PAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135403
• Other study ID #: DHF-00187-01
• Status: Recruiting
• Start date: November 20, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: October 2023
• Source: Kestra Medical Technologies, Inc.
• Contact: Ron Rowbotham, MSEE, CCRA
• Phone: 14255264913
• Email: ron.rowbotham[@]kestramedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5179
• Est. completion date: February 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Arrest

Intervention

Device:
• Defibrillation
External defibrillation from a wearable cardioverter defibrillator

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Kestra Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appropriate shock rate per month	Number of appropriate shocks/cumulative months of WCD use	Up to 3 years
Other	Appropriate shock rate	Percent of patients who experience at least one appropriate shock	Up to 3 years
Other	Total Shocks delivered	Number of shocks delivered	Up to 3 years
Other	Shocks diverted	Number of shocks diverted by patients	Up to 3 years
Other	False positive shock alarm rate	Number of false positive shock alarms/cumulative WCD use	Up to 3 years
Other	True positive shock alarm rate	Number of true positive shock alarms/cumulative WCD use	Up to 3 years
Other	Adverse events	Adverse events related to use of the WCD	Up to 3 years
Other	Average daily device use	Average daily use of the WCD in hours per day	Up to 3 years
Other	Cumulative device use	Cumulative device use in days	Up to 3 years
Primary	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
Primary	Inappropriate shocks per patient month	Total inappropriate shocks/cumulative months of WCD use for all patients = 0.0075	Up to 3 years
Secondary	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
Secondary	Inappropriate shock rate	Percent of patients who experience at least one inappropriate shock (report only)	Up to 3 years