Remote Interrogation in Rural Emergency Departments

Heart Failure Clinical Trial

— REM RED  

Official title:

Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02421549
• Other study ID #: 60054491
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care.

Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

2. Are 18 years of age or older.

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

4. Are willing and able to complete a 30-60 day follow up phone call.

Exclusion Criteria:

1. Are unwilling to provide written informed consent.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiovascular Disease
• Cardiovascular Diseases
• Emergencies
• Heart Disease
• Heart Diseases
• Heart Failure

Intervention

Device:
• Unpaired remote monitoring transmitter

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Device Interrogation	ED check in time until time of device interrogation	1 day
Primary	Time to Clinical Specialist Treatment Decision	ED check in time to time of clinical specialist treatment decision.	1 day
Secondary	Health Care Utilization Rate	Device related hospitalizations, ED visits and unscheduled office visits/urgent care visits within 30 days of the initial ED visit.	Within 30 days of initial ED visit