RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-11-20
Study Completion:2025-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05135403

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patient prescribed the ASSURE wearable cardioverter defibrillator
  2. * Provided written informed consent to participate in the ASSURE Patient Registry
  1. * Patients who do not meet the Inclusion criteria

Contacts and Locations

Study Contact

Kristin Eis, BSChE, MBA
CONTACT
14256547596
kristin.eis@kestramedical.com

Principal Investigator

Jeanne Poole, M.D.
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Kestra Medical Technologies, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-20
Study Completion Date2025-02-01

Study Record Updates

Study Start Date2021-11-20
Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Sudden Cardiac Arrest