Back to resultsRapidShock Post-Approval Study
Primary Purpose
Cardiac Arrest
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RapidShock
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest
Eligibility Criteria
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
Sites / Locations
- Ventura County Fire Department
- Colorado Springs Fire Department
- East Baton Rouge Parish EMS
- Detroit Fire Department
- M Health Fairview EMS
- Fort Worth Fire Department
- San Antonio Fire
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
RapidShock
Arm Description
Patients receiving xseries device with rapid shock enabled
Outcomes
Primary Outcome Measures
Algorithm accuracy
Accuracy of the algorithm compared to manual annotation for each rhythm
Secondary Outcome Measures
Full Information
NCT ID
NCT04014842
First Posted
April 25, 2019
Last Updated
January 30, 2023
Sponsor
Zoll Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04014842
Brief Title
RapidShock Post-Approval Study
Official Title
Post-Approval Study for Reconfirmation Analysis Mode Algorithm
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RapidShock
Arm Type
Other
Arm Description
Patients receiving xseries device with rapid shock enabled
Intervention Type
Device
Intervention Name(s)
RapidShock
Intervention Description
Use of the Reconfirmation Analysis Mode algorithm
Primary Outcome Measure Information:
Title
Algorithm accuracy
Description
Accuracy of the algorithm compared to manual annotation for each rhythm
Time Frame
average of up to 1 hour after device placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ventura County Fire Department
City
Camarillo
State/Province
California
ZIP/Postal Code
93010
Country
United States
Facility Name
Colorado Springs Fire Department
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
East Baton Rouge Parish EMS
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70807
Country
United States
Facility Name
Detroit Fire Department
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48234
Country
United States
Facility Name
M Health Fairview EMS
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55106
Country
United States
Facility Name
Fort Worth Fire Department
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76115
Country
United States
Facility Name
San Antonio Fire
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RapidShock Post-Approval Study
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