Trial Outcomes & Findings for Hospital Wearable Defibrillator Inpatient Study (NCT NCT02122549)

Results Overview

The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

24 hours or longer

Results posted on

2017-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	HWD1000 Subjects using HWD1000 HWD1000: Wearable cardioverter-defibrillator designed for inpatient use
Overall Study STARTED	59
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hospital Wearable Defibrillator Inpatient Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HWD1000 n=59 Participants Subjects using HWD1000 HWD1000: Wearable cardioverter-defibrillator designed for inpatient use
Age, Continuous	55.5 Years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours or longer

Population: Subjects who wore the HWD 1000 for a minimum of 24 hours.

The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).

Outcome measures

Outcome measures
Measure	HWD1000 n=38 Participants Subjects wearing the HWD 1000.
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. Neither lead used for monitoring	0.53 percentage of time worn Standard Deviation 0.73
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise. One lead not used for monitoring	2.54 percentage of time worn Standard Deviation 3.16

Adverse Events

HWD1000

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HWD1000 n=59 participants at risk Subjects using HWD1000 HWD1000: Wearable cardioverter-defibrillator designed for inpatient use
Skin and subcutaneous tissue disorders Skin Iritation	0.00% 0/59

Additional Information

Vice President of Medical Affairs

ZOLL

Phone: 412-968-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60