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RapidShock Post-Approval Study

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04014842
Collaborator
(none)
2,500
Enrollment
7
Locations
1
Arm
69.1
Anticipated Duration (Months)
357.1
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: RapidShock
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-Approval Study for Reconfirmation Analysis Mode Algorithm
Actual Study Start Date :
Feb 26, 2019
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: RapidShock

Device: RapidShock
Use of the Reconfirmation Analysis Mode algorithm

Outcome Measures

Primary Outcome Measures

  1. Algorithm accuracy [average of up to 1 hour after device placement]

    Accuracy of the algorithm compared to manual annotation for each rhythm

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ventura County Fire Department Camarillo California United States 93010
2 Colorado Springs Fire Department Colorado Springs Colorado United States 80910
3 Broward County Sheriff's Office Fire Rescue Fort Lauderdale Florida United States 33312
4 East Baton Rouge Parish EMS Baton Rouge Louisiana United States 70807
5 Detroit Fire Department Detroit Michigan United States 48234
6 M Health Fairview EMS Saint Paul Minnesota United States 55106
7 Fort Worth Fire Department Fort Worth Texas United States 76115

Sponsors and Collaborators

  • Zoll Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT04014842
Other Study ID Numbers:
  • 12701
First Posted:
Jul 10, 2019
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Jan 24, 2022