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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Sudden Cardiac Arrest
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington Medical Center, Seattle, Washington, United States, 98033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult patient prescribed the ASSURE wearable cardioverter defibrillator
  • * Provided written informed consent to participate in the ASSURE Patient Registry
  • * Patients who do not meet the Inclusion criteria

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kestra Medical Technologies, Inc.,

Jeanne Poole, M.D., PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2025-02-01