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NCT04014842 Clinical Trial

RapidShock Post-Approval Study

Cardiac Arrest Clinical Trial

Official title:
Post-Approval Study for Reconfirmation Analysis Mode Algorithm

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04014842
Other study ID # 12701
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 26, 2019
Est. completion date November 30, 2024

Study information
Verified date January 2023
Source Zoll Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 2500
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• RapidShock
Use of the Reconfirmation Analysis Mode algorithm

Locations
Country Name City State
United States East Baton Rouge Parish EMS Baton Rouge Louisiana
United States Ventura County Fire Department Camarillo California
United States Colorado Springs Fire Department Colorado Springs Colorado
United States Detroit Fire Department Detroit Michigan
United States Fort Worth Fire Department Fort Worth Texas
United States M Health Fairview EMS Saint Paul Minnesota
United States San Antonio Fire San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Algorithm accuracy Accuracy of the algorithm compared to manual annotation for each rhythm average of up to 1 hour after device placement
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