MedTrace Logo

ASSURE WCD Clinical Evaluation - Detection and Safety Study

NCT03887052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-03-12

Study results available
· View outcomes & findings →

Summary

A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).

Conditions

  • Cardiac Arrest, Sudden

Interventions

DEVICE

ASSURE™ Wearable Cardioverter Defibrillator (WCD)

WCD with shock alarms and shock functionality disabled

Sponsors & Collaborators

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • Kestra Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeanne E. Poole, MD · University of Washington Medical Center, Seattle

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2019-06-18
Completion
2019-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887052 on ClinicalTrials.gov