Trial Outcomes & Findings for Heart Sounds Measurement Using the Wearable Cardioverter Defibrillator (HS-WCD) Study (NCT NCT02825966)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again).

Results posted on

2020-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	AUDICOR AM Device, Then LifeVest, Then AUDICOR AM Device First assigned to wear the AUDICOR device for 15 minutes. Then, assigned to wear the WCD during activities of daily living, including at least 6 hours of overnight wear. Total anticipated wear time with WCD is 12-16 hours. Finally, assigned to wear AUDICOR device for 15 minutes after finishing the WCD wear.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AUDICOR AM Device, Then LifeVest, Then AUDICOR AM Device n=35 Participants Assigned to wear the AUDICOR device first, then the WCD, and finally the AUDICOR device again.
Age, Continuous	47.1 Years STANDARD_DEVIATION 15.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Body-mass index	29.1 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes of sitting for each group of measurements (Audicor device, then LifeVest, then Audicor device again).

Population: All subjects participating in the study were adult patients (age ≥ 18 years).

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.

Outcome measures

Outcome measures
Measure	AUDICOR AM Device (First) Wear n=35 Participants First, assigned to wear AUDICOR device for 15 minutes.	LifeVest Wear n=35 Participants Subjects removed the AUDICOR device and wore the LifeVest device for 12-16 hours	AUDICOR AM Device (Second) Wear n=35 Participants Subjects removed the LifeVest and then wore the AUDICOR AM device for 15 minutes
To Establish Equivalence Between the Heart Sounds Data Recorded by the LifeVest and FDA-cleared AUDICOR AM System.	95.88 ms Standard Deviation 17.5	96.98 ms Standard Deviation 15.04	98.25 ms Standard Deviation 19.11

Adverse Events

AUDICOR AM Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LifeVest

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Operations

ZOLL

Phone: 4129683333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place