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.
Study Type
OBSERVATIONAL
Enrollment
1,104
smartphone APP to monitor remotely patients implanted with ICD
bedside transmitter to monitor remotely patients implanted with ICD
Prof Antonio Rapacciuolo,MD, PhD
Naples, Italy
RECRUITINGAdherence
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.