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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational [Patient Registry]
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Adult patient prescribed the ASSURE wearable cardioverter defibrillator

• Provided written informed consent to participate in the ASSURE Patient Registry

Locations
United States
Washington
University of Washington Medical Center
Recruiting
Seattle
Contact Information
Primary
Ron Rowbotham, MSEE, CCRA
ron.rowbotham@kestramedical.com
14255264913
Time Frame
Start Date: November 20, 2021
Estimated Completion Date: February 1, 2025
Participants
Target number of participants: 5179
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Kestra Medical Technologies, Inc.

This content was sourced from clinicaltrials.gov