Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study
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|ClinicalTrials.gov Identifier: NCT02825966|
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : December 2, 2020
Last Update Posted : December 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: AUDICOR then LifeVest then AUDICOR||Not Applicable|
To conduct a prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). To show equivalence, these data will be compared with the heart sounds data recorded by an FDA-cleared AUDCIOR AM device .
The study will enroll a minimum of 27 and a maximum of 35 subjects.
Participants will be adult patients (age ≥ 18 years) with at least seven patients over the age of 40 years. In addition, at least five patients with a history of heart failure will be included.
First, participants will wear the AUDICOR-AM device for 15 minutes while sitting quietly. Then, the AUDICOR device will be removed and the participants will wear the WCD for 15 minutes while sitting quietly. Next, while wearing the WCD, participants will perform various activities of daily living, including at least 6 hours of overnight wear. Finally, the WCD will be removed and the participants will wear the AUDICOR again for 15 minutes while sitting quietly.
This is a single center, prospective, observational study. This is a non-significant risk device study as all biological study parameters will be measured noninvasively with the WCD defibrillation capability disabled. In addition, the study device will not be used as a replacement for regularly prescribed therapies or diagnostics.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Each subject first wears the AUDICOR-AM device for 15 minutes while sitting. Then the AUDICOR device is removed and the subject wears the WCD for 12-16 hours. After the WCD wear period, the WCD device is removed and the subject wears the AUDICOR device again for 15 minutes.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD): Study Protocol|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
AUDICOR then LifeVest then AUDICOR
First, assigned to wear AUDICOR device for 15 minutes. Then assigned to wear the WCD, including 6 hours of overnight wear. Total anticipated wear time with WCD is 12-16 hours. Finally, assigned to wear the AUDICOR device for another 15 minutes after finishing the WCD wear.
Device: AUDICOR then LifeVest then AUDICOR
Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.
- To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System. [ Time Frame: 15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again). ]Equivalence of the LifeVest device to the AUDICOR device was established by comparing the electromechanical activation time (EMAT) data of each device, collected during quiet sitting. The outcome was reported as the difference in EMAT measured by the LifeVest and AUDICOR device.
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): NCT02825966
|United States, Ohio|
|MedPace Phase 1 Clinic|
|Cincinnati, Ohio, United States, 45227|
|Study Director:||Steve Szymkiewicz, MD||VP Medical Affairs|