N/A
N=83
Remote Device Interrogation In The Emergency Department
Heart Disease · Cardiovascular Disease · Heart Failure · Arrhythmias, Cardiac
Bottom Line
View on ClinicalTrials.gov: NCT01871090 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Time to Interrogation — 25; 210 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unpaired remote monitoring transmitter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Interrogation |
25; 210 | — |
| SECONDARY Time to Clinical/Treatment Decision |
204; 270 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Present to Emergency Department with an implanted pacemaker or defibrillator.
- Are 18 years of age or older, or of legal age to give informed consent specific to state law.
- Are willing and able to provide informed consent for study participation.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01871090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.