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HeartStart FRx Defibrillator Event Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250857
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Philips Clinical & Medical Affairs Global

Brief Summary:
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.

Condition or disease Intervention/treatment
Sudden Cardiac Arrest Device: HeartStart FRX

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: HeartStart FRx Defibrillator Event Registry
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort Intervention/treatment
Suspected Sudden Cardiac Arrest
All subject with suspected of a circulatory arrest for any cause.
Device: HeartStart FRX
Automated External Defibrillator




Primary Outcome Measures :
  1. Algorithm accuracy [ Time Frame: Up to 15 minutes after device placement ]
    Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.

  2. Shock Delivery [ Time Frame: 1 day ]
    Percentage of events where a shock was delivered when indicated.

  3. Unexpected adverse events. [ Time Frame: 1 day ]
    Frequency and severity of unexpected adverse events.

  4. Unanticipated adverse device effects (UADE) [ Time Frame: 1 day ]
    Unanticipated adverse device effects (UADE)


Secondary Outcome Measures :
  1. Time Intervals [ Time Frame: 1 day ]
    Measurements of device performance time intervals.

  2. Device Preparation [ Time Frame: 1 day ]
    Percentage of events where the device prepared to shock.

  3. Shock Energy Delivered [ Time Frame: 1 day ]
    The amount of shock energy delivered as measured in joules with each shock.

  4. Pad Replacement [ Time Frame: 1 day ]
    Frequency of pad replacement.

  5. User [ Time Frame: 1 day ]
    Frequency of user pressing the shock button.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.
Criteria

Inclusion Criteria:

  • Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
  • Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

Exclusion Criteria:

  • AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
  • AED used for training purposes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250857


Contacts
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Contact: Barb Fink 724-708-7048 barb.fink@philips.com

Locations
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United States, Pennsylvania
Philips Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Barb Fink    724-708-7048    barb.fink@philips.com   
Principal Investigator: Gerrit Noordergraaf, MD         
Sponsors and Collaborators
Philips Clinical & Medical Affairs Global
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Responsible Party: Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier: NCT04250857    
Other Study ID Numbers: MATC-ECR-Registry-2018-10295
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes