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出境医 / 临床实验 / RapidShock Post-Approval Study

RapidShock Post-Approval Study

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
Cardiac Arrest Device: RapidShock Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 26, 2019
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024
Arms and Interventions
Arm Intervention/treatment
RapidShock Device: RapidShock
Use of the Reconfirmation Analysis Mode algorithm
Outcome Measures
Primary Outcome Measures :
  1. Algorithm accuracy [ Time Frame: average of up to 1 hour after device placement ]
    Accuracy of the algorithm compared to manual annotation for each rhythm


Eligibility Criteria
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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, California
Ventura County Fire Department
Camarillo, California, United States, 93010
United States, Louisiana
East Baton Rouge Parish EMS
Baton Rouge, Louisiana, United States, 70807
United States, Texas
Fort Worth Fire Department
Fort Worth, Texas, United States, 76115
Sponsors and Collaborators
Zoll Medical Corporation
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date March 9, 2020
Actual Study Start Date  ICMJE February 26, 2019
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		Algorithm accuracy [ Time Frame: average of up to 1 hour after device placement ]
Accuracy of the algorithm compared to manual annotation for each rhythm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RapidShock Post-Approval Study
Official Title  ICMJE Post-Approval Study for Reconfirmation Analysis Mode Algorithm
Brief Summary Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE Device: RapidShock
Use of the Reconfirmation Analysis Mode algorithm
Study Arms  ICMJE RapidShock
Intervention: Device: RapidShock
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		2500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2024
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014842
Other Study ID Numbers  ICMJE 12701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zoll Medical Corporation
Study Sponsor  ICMJE Zoll Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zoll Medical Corporation
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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