Cardiac Arrhythmias, Heart Failure, Sudden Cardiac Death
Conditions
Keywords
Connectivity, Remote monitoring, Cardiac Implantable Electronic Device
Brief summary
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.
Detailed description
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.
Interventions
DEVICEsmartphone APP based remote monitoring
smartphone APP to monitor remotely patients implanted with ICD
DEVICEbedside transmitter based remote monitoring
bedside transmitter to monitor remotely patients implanted with ICD
Sponsors
Federico II University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients implanted with an ICD as for standard indications * Over 18 years of age * Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations
Exclusion criteria
* Subject who is, or is expected to be inaccessible for follow-up * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 12 months | The adherence will be measured through the following endpoints: • Compliance with RM quantified as percentage of patients who registered with the smartphone App |
| Effectiveness | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefits in CRT area: | 12 Months | Association between patient symptom-triggered transmissions and HF events or other clinical events detected by device diagnostics |
| Clinical benefits in ICD therapies | 12 months | Clinical action taken as a result of appropriate or inappropriate ICD therapies |
Countries
Italy
Contacts
Primary ContactAntonio Rapacciuolo, MD, PhD
Outcome results
None listed