Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

Aim of the study The purpose of this study is to evaluate the clinical benefit of a dedicated remote monitoring system (RPM) in the management of patients with heart failure and implanted with ICDs and CRT-D.

The clinical benefit will be assessed by:

• Increased cardiovascular events (death, myocardial infarction, hospitalization).
• Events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular tachycardia or ventricular fibrillation.
• Autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life questionnaire.

The primary endpoint of this study is to estimate the incidence (and its accuracy) of the first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).

Inclusion criteria

• Subjects >18 years
• patients implanted or eligible for implant with ICD-CRT-D, accordingly with guidelines of the centers, for heart failure treatment and/or primary prevention of sudden death

Exclusion criteria

• Presence of clinically overt heart failure.
• Myocardial infarction within 2 months before enrolment.
• Significant concurrent illness or condition severely limiting life expectancy.
• Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
• History of drug or alcohol abuse within the last 2 years.
• Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.