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

NCT05135403 | Recruiting FDA Device

• 1 other identifier: DHF-00187-01
• Study Type: observational
• Target: 5,179
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• First shock conversion rate

  Up to 3 years

• Inappropriate shock rate

  Up to 3 years

Other Outcomes (9)

• Appropriate shock rate per month

  Up to 3 years

• Appropriate shock rate

  Up to 3 years

• Total Shocks delivered

  Up to 3 years

Study Arms (1)

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

Interventions

Defibrillation DEVICE

External defibrillation from a wearable cardioverter defibrillator

ASSURE Registry Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Kestra Medical Technologies, Inc.: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98033, United States

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Jeanne Poole, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Eis, BSChE, MBA

CONTACT

14256547596; kristin.eis@kestramedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: November 26, 2021
• Study Start: November 20, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)