NCT05175937

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,104 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrhythmias
• Sudden Cardiac Death
• Heart Failure

Interventions

Type	Name	Description
DEVICE	smartphone APP based remote monitoring	smartphone APP to monitor remotely patients implanted with ICD
DEVICE	bedside transmitter based remote monitoring	bedside transmitter to monitor remotely patients implanted with ICD

Timeline

• Start date: 2021-09-22
• Primary completion: 2023-12-31
• Completion: 2025-04-01
• First posted: 2022-01-04
• Last updated: 2022-01-04

Locations

1 site across 1 country: Italy