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

Recruiting

• Conditions: Sudden Cardiac Death; Heart Failure; Cardiac Arrhythmias
• Interventions: Device: bedside transmitter based remote monitoring; Device: smartphone APP based remote monitoring

• Registration Number: NCT05175937
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2021-09-22
• Study First Submitted: 2021-11-18
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-15
• Last Update Submitted: 2021-12-15
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04
• Primary Completion: 2023-12-31
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bedside transmitter group	bedside transmitter based remote monitoring	Patient wearing ICD monitored remotely through a bedside transmitter
APP group	smartphone APP based remote monitoring	Patient wearing ICD with Bluetooth® technology and smartphone APP based remote monitoring

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Prof Antonio Rapacciuolo,MD, PhD; 🇮🇹 Naples, Italy