Trial Outcomes & Findings for Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study (NCT NCT02188147)

NCT ID: NCT02188147

Last Updated: 2023-02-21

Results Overview

% time the device detected noise on both leads at the same time.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: enrollment to 30 days
• Results posted on: 2023-02-21

Participant Flow

Participant milestones

Measure	SWD 1000 Patients who presented to the emergency room after syncope, and their syncopal event was believed to have a cardiac or undiagnosed cause. In this group participants agreed to wear the Short Term Wearable Defibrillator 1000 (SWD 1000) after discharge for up to 14 days.
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

Baseline characteristics by cohort

Measure	SWD 1000 n=39 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Age, Continuous	44.4 years STANDARD_DEVIATION 17.8 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants
Height	67.5 inches STANDARD_DEVIATION 3.8 • n=5 Participants
Weight	185.2 pounds STANDARD_DEVIATION 51.6 • n=5 Participants
Blood pressure Systolic	127 mm Hg STANDARD_DEVIATION 18 • n=5 Participants
Blood pressure Diastolic	76 mm Hg STANDARD_DEVIATION 13 • n=5 Participants
Heart rate	76 beats per minute STANDARD_DEVIATION 15 • n=5 Participants
Respiration rate	16.4 breaths per minute STANDARD_DEVIATION 2.5 • n=5 Participants
Prior syncope	29 Participants n=5 Participants
Past history of myocardial infarction	3 Participants n=5 Participants
Past history of heart failure	3 Participants n=5 Participants
Past history of diabetes	9 Participants n=5 Participants
Past history of atrial fibrillation	2 Participants n=5 Participants
Past history of renal failure	1 Participants n=5 Participants
Active pacemaker	1 Participants n=5 Participants
Family history of sudden death	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: enrollment to 30 days

Population: Subjects who used the SWD1000 for at least 24 hours

% time the device detected noise on both leads at the same time.

Outcome measures

Measure	SWD 1000 n=30 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Device Unable to Monitor Due to ECG Noise	1.5 percentage of time worn Interval 0.59 to 2.39

PRIMARY outcome

Timeframe: enrollment to 30 days

Population: SWD 1000 participants who used the device at least 24 hours.

% time that the device is monitoring using only one lead due to noise detected on the other lead

Outcome measures

Measure	SWD 1000 n=30 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Device Monitoring Using Only One ECG Lead	2.5 percentage of time worn Interval 2.44 to 4.18

PRIMARY outcome

Timeframe: enrollment to 30 days

Followup care for syncope - outpatient medical care visits

Outcome measures

Measure	SWD 1000 n=39 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Followup Care Visits	17 Participants

PRIMARY outcome

Timeframe: enrollment to 30 days

Followup care for syncope - returned to ER or admitted to hospital

Outcome measures

Measure	SWD 1000 n=39 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
ER or Hospitalization	4 Participants

SECONDARY outcome

Timeframe: enrollment to 30 days

Average time the SWD 1000 was used by participants

Outcome measures

Measure	SWD 1000 n=39 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Duration of Use	6.1 days Standard Deviation 5.2

POST_HOC outcome

Timeframe: enrollment to 30 days

SWD 1000 alarms given to alert user of detected noise on one or more ECG leads

Outcome measures

Measure	SWD 1000 n=39 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Noise Alarms	15 count of alarms per subject Standard Deviation 17

POST_HOC outcome

Timeframe: enrollment to 30 days

Device alarms given because an arrhythmia was detected (may or may not be real arrhythmia)

Outcome measures

Measure	SWD 1000 n=39 Participants Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Arrhythmia Alarms	9.9 number of alarms per subjects Standard Deviation 31.1

Adverse Events

SWD 1000

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SWD 1000 n=39 participants at risk Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)
Skin and subcutaneous tissue disorders Skin rash or irritation	25.6% 10/39 • Number of events 12 • 30 days
Injury, poisoning and procedural complications Inappropriate shock	7.7% 3/39 • Number of events 3 • 30 days

Additional Information

Vice President Medical Affairs

ZOLL

Phone: 412-968-3333

Email: stevens@zoll.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place