MOnitoring REsynchronization deviCes and cARdiac patiEnts

Summary

The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices

1. Remote monitoring with CareLink Network System
2. Standard management of the disease by means of scheduled routine in-patient follow-ups;

and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

Conditions

• Heart Failure

Interventions

DEVICE

Medtronic CareLink® Network

Continuous monitoring via a disease remote management system. Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

  lead INDUSTRY

Principal Investigators

• Haran Burri, MD · University Hospitals of Geneva Switzerland

• Giuseppe Boriani, MD · Policlinico Universitario Sant'Orsola, Bologna, Italy

• Renato Pietro Ricci, MD · Azienda Ospedaliera San Filippo Neri, Roma, Italy

• Aurelio Quesada, MD · Hospital General Universitario de Valencia, Spain

• Stefano Favale, MD · Policlinico Universitario di Bari, Italy

• Josef Kautzner, MD · IKEM, Prague, Czech Republic

• Antoine Da Costa, MD · Hopital du Nord, Saint Etienne, France

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2015-12-31

Completion

2016-01-31

Countries

• Czechia
• France
• Greece
• Hungary
• Israel
• Italy
• Netherlands
• Slovakia
• Spain
• Switzerland

Study Locations