An observational study in Cardiac Arrhythmias, Sudden Cardiac Death and Heart Failure, sponsored by Federico II University. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by Federico II University · Observational
The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.
REACTION is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. After implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or RF) he/she wears, if he/she gives the consent to partecipate. It is not a randomized study. Patients will be enrolled consecutively until reaching the sample defined for both the arms.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 1,104 is above the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The sample size will be about 1104 patients; 736 patients implanted with Bluetooth technology devices and 368 patients followed with traditional remote control.
Exclusion Criteria:
Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring
Device: smartphone APP based remote monitoring
Patient wearing ICD monitored remotely through a bedside transmitter
Device: bedside transmitter based remote monitoring
smartphone APP to monitor remotely patients implanted with ICD
bedside transmitter to monitor remotely patients implanted with ICD
Adherence
The adherence will be measured through the following endpoints: • Compliance with RM quantified as percentage of patients who registered with the smartphone App
Time frame: 12 months
Effectiveness
The effectiveness based on the comparison between the App monitoring and the traditional remote control will be assessed through the following endpoints: • Percentage of time (days) with an active connection between device and the transmitter/smartphone app
Time frame: 12 months
Clinical benefits in CRT area:
Association between patient symptom-triggered transmissions and HF events or other clinical events detected by device diagnostics
Time frame: 12 Months
Clinical benefits in ICD therapies
Clinical action taken as a result of appropriate or inappropriate ICD therapies
Time frame: 12 months
Plan to share: Undecided
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Federico II University