RapidShock Post-Approval Study

NCT ID: NCT04014842

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Cardiac Arrest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RapidShock

Patients receiving xseries device with rapid shock enabled

Group Type OTHER

RapidShock

Intervention Type DEVICE

Use of the Reconfirmation Analysis Mode algorithm

Interventions

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RapidShock

Use of the Reconfirmation Analysis Mode algorithm

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ventura County Fire Department

Camarillo, California, United States

Site Status

Colorado Springs Fire Department

Colorado Springs, Colorado, United States

Site Status

East Baton Rouge Parish EMS

Baton Rouge, Louisiana, United States

Site Status

Detroit Fire Department

Detroit, Michigan, United States

Site Status

M Health Fairview EMS

Saint Paul, Minnesota, United States

Site Status

Fort Worth Fire Department

Fort Worth, Texas, United States

Site Status

San Antonio Fire

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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12701

Identifier Type: -

Identifier Source: org_study_id

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