RapidShock Post-Approval Study

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

Completed

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ventura County Fire Department, Camarillo, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RapidShock

Device

Use of the Reconfirmation Analysis Mode algorithm

Primary outcomes

Algorithm accuracy

Time frame: average of up to 1 hour after device placement

Accuracy of the algorithm compared to manual annotation for each rhythm

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Official study title

Post-Approval Study for Reconfirmation Analysis Mode Algorithm

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Jul 10, 2019
Registry last updated: Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed