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

Recruiting

• Conditions: Sudden Cardiac Arrest
• Interventions: Device: Defibrillation

• Registration Number: NCT05135403
• Lead Sponsor: Kestra Medical Technologies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-30
• Study Start: 2021-11-20
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-11-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5179

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASSURE Registry Patients	Defibrillation	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 Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States