NCT02825966

Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study

Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD): Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A prospective, validation study to evaluate the data accuracy of heart sounds recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD). These data will be compared with the heart sounds data recorded by an FDA-cleared device AUDICOR AM device.

Detailed description

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	AUDICOR then LifeVest then AUDICOR	Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-07-07
• Last updated: 2020-12-02
• Results posted: 2020-12-02

Locations

1 site across 1 country: United States