REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology

Conditions
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Cardiac Arrhythmias, Sudden Cardiac Death, Heart Failure

Intervention / Treatment
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* Device: smartphone APP based remote monitoring
* Device: bedside transmitter based remote monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| APP group<br>Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring | Device: smartphone APP based remote monitoring<br>* smartphone APP to monitor remotely patients implanted with ICD<br>|
| Bedside transmitter group<br>Patient wearing ICD monitored remotely through a bedside transmitter | Device: bedside transmitter based remote monitoring<br>* bedside transmitter to monitor remotely patients implanted with ICD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | The adherence will be measured through the following endpoints: • Compliance with RM quantified as percentage of patients who registered with the smartphone App | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefits in CRT area: | Association between patient symptom-triggered transmissions and HF events or other clinical events detected by device diagnostics | 12 Months | 
| Clinical benefits in ICD therapies | Clinical action taken as a result of appropriate or inappropriate ICD therapies | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connectivity, Remote monitoring, Cardiac Implantable Electronic Device