RapidShock Post-Approval Study

July 22, 2024 updated by: Zoll Medical Corporation

Post-Approval Study for Reconfirmation Analysis Mode Algorithm

Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2756

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Camarillo, California, United States, 93010
        • Ventura County Fire Department
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Colorado Springs Fire Department
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70807
        • East Baton Rouge Parish EMS
    • Michigan
      • Detroit, Michigan, United States, 48234
        • Detroit Fire Department
    • Minnesota
      • Saint Paul, Minnesota, United States, 55106
        • M Health Fairview EMS
    • Texas
      • Fort Worth, Texas, United States, 76115
        • Fort Worth Fire Department
      • San Antonio, Texas, United States, 78229
        • San Antonio Fire

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.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 8 years of age or older and weight ≥ 55 lbs (25 kgs)
  • Out-of-hospital cardiac arrest (OOHCA)
  • Non-traumatic cardiac arrest

Exclusion Criteria:

  • Weight less than 55 lbs (25 kgs)
  • Do not attempt resuscitation (DNAR) orders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RapidShock
Patients receiving xseries device with rapid shock enabled
Device: RapidShock
Use of the Reconfirmation Analysis Mode algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm accuracy
Time Frame: average of up to 1 hour after device placement
Accuracy of the algorithm compared to manual annotation for each rhythm
average of up to 1 hour after device placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoll Medical Corporation

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 Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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