Trial Outcomes & Findings for Remote Device Interrogation In The Emergency Department (NCT NCT01871090)

Last Updated: 2019-02-15

Results Overview

Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.

Recruitment status

COMPLETED

Study phase

Target enrollment

99 participants

Primary outcome timeframe

On day of Emergency Department admission

Results posted on

2019-02-15

Participant Flow

Subjects enrolled from 20-September-2013 to 14-April-2015 from the Genesis Healthcare Emergency Department located in Zanesville, Ohio.

There were 16 screen failures because at the time of their enrollment, the patient group had met maximum enrollment for their patient group (compatible vs. non-compatible cardiac device) under the initial protocol.

Participant milestones

Participant milestones
Measure	Interrogation With Unpaired Remote Monitoring Transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer Interrogation with programmer according to usual standard of care
Overall Study STARTED	35	48
Overall Study COMPLETED	33	25
Overall Study NOT COMPLETED	2	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Interrogation With Unpaired Remote Monitoring Transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer Interrogation with programmer according to usual standard of care
Overall Study Interrogation not done in Emergency Room	1	22
Overall Study Interrogation not completed correctly	1	0
Overall Study Subject Non-Compliance	0	1

Baseline Characteristics

Remote Device Interrogation In The Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interrogation With Unpaired Remote Monitoring Transmitter n=35 Participants Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer n=48 Participants Interrogation with programmer according to usual standard of care	Total n=83 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 18.6 • n=93 Participants	64.4 years STANDARD_DEVIATION 14.7 • n=4 Participants	65.5 years STANDARD_DEVIATION 16.4 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	7 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	41 Participants n=4 Participants	59 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	33 Participants n=93 Participants	41 Participants n=4 Participants	74 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: On day of Emergency Department admission

Outcome measures

Outcome measures
Measure	Interrogation With Unpaired Remote Monitoring Transmitter n=35 Participants Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer n=48 Participants Interrogation with programmer according to usual standard of care
Time to Interrogation	25 Minutes Interval 1.0 to 95.0	210 Minutes Interval 1.0 to 980.0

SECONDARY outcome

Timeframe: On day of Emergency Department admission

Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).

Outcome measures

Outcome measures
Measure	Interrogation With Unpaired Remote Monitoring Transmitter n=35 Participants Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer n=48 Participants Interrogation with programmer according to usual standard of care
Time to Clinical/Treatment Decision	204 Minutes Interval 67.0 to 354.0	270 Minutes Interval 24.0 to 874.0

OTHER_PRE_SPECIFIED outcome

Timeframe: On day of Emergency Department admission

Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).

Outcome measures

Outcome measures
Measure	Interrogation With Unpaired Remote Monitoring Transmitter n=35 Participants Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer n=48 Participants Interrogation with programmer according to usual standard of care
Length of Emergency Department Stay	261 Minutes Interval 109.0 to 547.0	245 Minutes Interval 66.0 to 874.0

Adverse Events

Interrogation With Unpaired Remote Monitoring Transmitter

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Interrogation With Programmer

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	Interrogation With Unpaired Remote Monitoring Transmitter n=35 participants at risk Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation With Programmer n=48 participants at risk Interrogation with programmer according to usual standard of care
Injury, poisoning and procedural complications Failed transmission from the study device to fax, email, or Merlin.Net	2.9% 1/35 • Number of events 1 • Adverse Events were reported while subject was in the Emergency Department.	0.00% 0/48 • Adverse Events were reported while subject was in the Emergency Department.

Additional Information

Todd Stirman, Clinical Manager

St Jude Medical, Inc.

Phone: (972) 526-9625

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place