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
|Condition or disease||Intervention/treatment|
|Sudden Cardiac Arrest||Device: HeartStart FRX|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1400 participants|
|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|
Suspected Sudden Cardiac Arrest
All subject with suspected of a circulatory arrest for any cause.
Device: HeartStart FRX
Automated External Defibrillator
- 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.
- Shock Delivery [ Time Frame: 1 day ]Percentage of events where a shock was delivered when indicated.
- Unexpected adverse events. [ Time Frame: 1 day ]Frequency and severity of unexpected adverse events.
- Unanticipated adverse device effects (UADE) [ Time Frame: 1 day ]Unanticipated adverse device effects (UADE)
- Time Intervals [ Time Frame: 1 day ]Measurements of device performance time intervals.
- Device Preparation [ Time Frame: 1 day ]Percentage of events where the device prepared to shock.
- Shock Energy Delivered [ Time Frame: 1 day ]The amount of shock energy delivered as measured in joules with each shock.
- Pad Replacement [ Time Frame: 1 day ]Frequency of pad replacement.
- User [ Time Frame: 1 day ]Frequency of user pressing the shock button.
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
|Contact: Barb Finkfirstname.lastname@example.org|
|United States, Pennsylvania|
|Monroeville, Pennsylvania, United States, 15146|
|Contact: Barb Fink 724-708-7048 email@example.com|
|Principal Investigator: Gerrit Noordergraaf, MD|