REMEDY: Remote Device Interrogation In The Emergency Department

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01871090
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Duration (Months): 21.9
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will enroll up to 100 patients total.

Expected duration of the study is 6 months. Once enrolled the patient will participate in the study for the duration of the Emergency Department stay, until discharged or admitted to the hospital.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease; Cardiovascular Disease; Heart Failure; Arrhythmias, Cardiac	Device: Unpaired remote monitoring transmitter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Remote Device Interrogation In The Emergency Department
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interrogation with unpaired remote transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.	Device: Unpaired remote monitoring transmitter; Unpaired remote monitoring transmitter; Other Names: St. Jude Medical Merlin@home remote monitoring transmitter
No Intervention: Interrogation with programmer Interrogation with programmer according to usual standard of care

Outcome Measures

Primary Outcome Measures

1. Time to Interrogation [On day of Emergency Department admission]

   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.

Secondary Outcome Measures

1. Time to Clinical/Treatment Decision [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).

Other Outcome Measures

1. Length of Emergency Department Stay [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Present to Emergency Department with an implanted pacemaker or defibrillator.

2. Are 18 years of age or older, or of legal age to give informed consent specific to state law.

3. Are willing and able to provide informed consent for study participation.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genesis Healthcare System	Zanesville	Ohio	United States	43701

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Marc Girsky, MD, Los Angeles Biomedical Research Institute at Harbor - UCLA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01871090
• Other Study ID Numbers: 60047158
• First Posted: Jun 6, 2013
• Last Update Posted: Feb 15, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: Remote Monitoring; Remote Care; Cardiac Resynchronization Therapy; Pacemaker; Implantable Cardioverter Defibrillator
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Emergencies

Study Results

Participant Flow

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

Arm/Group Title	Interrogation With Unpaired Remote Monitoring Transmitter	Interrogation With Programmer
Arm/Group Description	Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation with programmer according to usual standard of care
Period Title: Overall Study
STARTED	35	48
COMPLETED	33	25
NOT COMPLETED	2	23

Baseline Characteristics

Arm/Group Title	Interrogation With Unpaired Remote Monitoring Transmitter	Interrogation With Programmer	Total
Arm/Group Description	Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation with programmer according to usual standard of care	Total of all reporting groups
Overall Participants	35	48	83
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (18.6)	64.4 (14.7)	65.5 (16.4)
Sex: Female, Male (Count of Participants)
Female	17 48.6%	7 14.6%	24 28.9%
Male	18 51.4%	41 85.4%	59 71.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.9%	5 10.4%	6 7.2%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2.9%	2 4.2%	3 3.6%
White	33 94.3%	41 85.4%	74 89.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Time to Interrogation
Description	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.
Time Frame	On day of Emergency Department admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrogation With Unpaired Remote Monitoring Transmitter	Interrogation With Programmer
Arm/Group Description	Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation with programmer according to usual standard of care
Measure Participants	35	48
Median (Full Range) [Minutes]	25	210

2. Secondary Outcome

Title	Time to Clinical/Treatment Decision
Description	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).
Time Frame	On day of Emergency Department admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrogation With Unpaired Remote Monitoring Transmitter	Interrogation With Programmer
Arm/Group Description	Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation with programmer according to usual standard of care
Measure Participants	35	48
Median (Full Range) [Minutes]	204	270

3. Other Pre-specified Outcome

Title	Length of Emergency Department Stay
Description	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).
Time Frame	On day of Emergency Department admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interrogation With Unpaired Remote Monitoring Transmitter	Interrogation With Programmer
Arm/Group Description	Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter	Interrogation with programmer according to usual standard of care
Measure Participants	35	48
Median (Full Range) [Minutes]	261	245

Adverse Events

Time Frame	Adverse Events were reported while subject was in the Emergency Department.
Arm/Group Title	Interrogation With Unpaired Remote Monitoring Transmitter		Interrogation With Programmer
Arm/Group Description	Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter		Interrogation with programmer according to usual standard of care
All Cause Mortality
	Interrogation With Unpaired Remote Monitoring Transmitter		Interrogation With Programmer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Interrogation With Unpaired Remote Monitoring Transmitter		Interrogation With Programmer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Interrogation With Unpaired Remote Monitoring Transmitter		Interrogation With Programmer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)		0/48 (0%)
Injury, poisoning and procedural complications
Failed transmission from the study device to fax, email, or Merlin.Net	1/35 (2.9%)	1	0/48 (0%)	0

Limitations/Caveats

23 subjects in the control group and 2 in the study group were not included due to their interrogation not being done in the emergency department.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.