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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APP group | Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring |
| |
| Bedside transmitter group | Patient wearing ICD monitored remotely through a bedside transmitter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartphone APP based remote monitoring | Device | smartphone APP to monitor remotely patients implanted with ICD |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The sample size will be about 1104 patients; 736 patients implanted with Bluetooth technology devices and 368 patients followed with traditional remote control.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Rapacciuolo, MD, PhD | Contact | 081-7461111 | antonio.rapacciuolo@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof Antonio Rapacciuolo,MD, PhD | Recruiting | Naples | 80128 | Italy |
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| bedside transmitter based remote monitoring | Device | bedside transmitter to monitor remotely patients implanted with ICD |
|
Clinical action taken as a result of appropriate or inappropriate ICD therapies
| 12 months |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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