Remote Device Interrogation In The Emergency Department (REMEDY)

Abbott

Status: Completed

Conditions: Arrhythmias, Cardiac; Heart Failure; Heart Disease; Cardiovascular Disease

Treatments: Device: Unpaired remote monitoring transmitter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01871090

60047158

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Interrogation with unpaired remote transmitter

Active Comparator group

Description:

Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.

Treatment:

Device: Unpaired remote monitoring transmitter

Interrogation with programmer

No Intervention group

Description:

Interrogation with programmer according to usual standard of care