Trial Outcomes & Findings for Proof of Concept Study for 1 Lead Patch Technology (NCT NCT02533531)
NCT ID: NCT02533531
Last Updated: 2018-04-06
Results Overview
Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.
TERMINATED
NA
1 participants
Between 7 and 14 days
2018-04-06
Participant Flow
Participant milestones
| Measure |
1-Lead Outpatient Telemetry
1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.
1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
|
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
1-Lead Outpatient Telemetry
1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.
1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
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|---|---|
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Overall Study
Device did not turn on
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1
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Baseline Characteristics
The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed.
Baseline characteristics by cohort
| Measure |
1-Lead Outpatient Telemetry
n=1 Participants
1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.
1-Lead Patch: The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed.
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Age, Categorical
Between 18 and 65 years
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0 Participants
The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed.
|
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Age, Categorical
>=65 years
|
0 Participants
The single enrolled subject did not complete study procedure. Therefore no data was collected / analyzed.
|
PRIMARY outcome
Timeframe: Between 7 and 14 daysPopulation: Data were not collected.
Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between 7 and 14 daysPopulation: Data were not collected.
Successful performance of the 1-Lead Patch adhesive throughout the study period for each subject. Subject skin irritation will be assessed upon initial placement of the 1-Lead Patch by the clinical caregiver. Subjects will be asked to self-assess skin irritation and to report to the clinician at the end of the trail period. Data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
1-Lead Outpatient Telemetry
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place