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

Heart Failure Clinical Trial

— REACTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175937
• Other study ID #: 137/21
• Status: Recruiting
• Start date: September 22, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: December 2021
• Source: Federico II University
• Contact: Antonio Rapacciuolo, MD, PhD
• Phone: 081-7461111
• Email: antonio.rapacciuolo[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1104
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Device:
• smartphone APP based remote monitoring
smartphone APP to monitor remotely patients implanted with ICD
• bedside transmitter based remote monitoring
bedside transmitter to monitor remotely patients implanted with ICD

Locations

Country	Name	City	State
Italy	Prof Antonio Rapacciuolo,MD, PhD	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

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