NCT04014842

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,756

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

4.8 years

First QC Date

April 25, 2019

Last Update Submit

July 22, 2024

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Algorithm accuracy

    Accuracy of the algorithm compared to manual annotation for each rhythm

    average of up to 1 hour after device placement

Study Arms (1)

RapidShock

OTHER

Patients receiving xseries device with rapid shock enabled

Device: RapidShock

Interventions

RapidShockDEVICE

Use of the Reconfirmation Analysis Mode algorithm

RapidShock

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ventura County Fire Department

Camarillo, California, 93010, United States

Location

Colorado Springs Fire Department

Colorado Springs, Colorado, 80910, United States

Location

East Baton Rouge Parish EMS

Baton Rouge, Louisiana, 70807, United States

Location

Detroit Fire Department

Detroit, Michigan, 48234, United States

Location

M Health Fairview EMS

Saint Paul, Minnesota, 55106, United States

Location

Fort Worth Fire Department

Fort Worth, Texas, 76115, United States

Location

San Antonio Fire

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

July 10, 2019

Study Start

February 26, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(7)