RapidShock Post-Approval Study

Post-Approval Study for Reconfirmation Analysis Mode Algorithm

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04014842

Enrollment

2756

Registered

2019-07-10

Start date

2019-02-26

Completion date

2023-12-31

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief summary

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

Interventions

DEVICERapidShock

Use of the Reconfirmation Analysis Mode algorithm

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026