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

Federico II University

Status

Enrolling

Conditions

Heart Failure

Sudden Cardiac Death

Cardiac Arrhythmias

Treatments

Device: smartphone APP based remote monitoring

Device: bedside transmitter based remote monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT05175937

137/21

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,104 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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