Remote Device Interrogation In The Emergency Department

Heart Failure Clinical Trial

— REMEDY  

Official title:

Remote Device Interrogation In The Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871090
• Other study ID #: 60047158
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: July 2015

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

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

Intervention

Device:
• Unpaired remote monitoring transmitter
Unpaired remote monitoring transmitter

Locations

Country	Name	City	State
United States	Genesis Healthcare System	Zanesville	Ohio

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	Length of Emergency Department Stay	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).	On day of Emergency Department admission
Primary	Time to Interrogation	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.	On day of Emergency Department admission
Secondary	Time to Clinical/Treatment Decision	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).	On day of Emergency Department admission