NCT01723865

Clinical Efficacy of Remote Monitoring in the Management of Heart Failure

Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 988 (actual)
• Sponsor: Effect Group, Italy · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients with heart failure having an ICD-CRT implanted. Study purpose The purpose of this study is to test the hypothesis that the monitoring of specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical course of patients with heart failure. Study design This is a prospective observational study, comparing clinical course of patients with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring system (with or without weight and pressure external sensors) or followed by conventional ambulatory visits. Primary endpoints The primary endpoint of this study is to document no superiority of unplanned hospital access for cardiac reasons (included access to the emergency units ) or death for cardiovascular causes in remote monitoring group (with or without weight and pressure external sensors) compared to conventional follow-up (usual care group).

Detailed description

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).

Conditions

• Heart Failure

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-11-08
• Last updated: 2014-08-05

Locations

16 sites across 1 country: Italy