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Trials
Published in: Trials 1/2009

Open Access 01-12-2009 | Study protocol

Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

Authors: Maurizio Marzegalli, Maurizio Landolina, Maurizio Lunati, Giovanni B Perego, Alessia Pappone, Giuseppe Guenzati, Carlo Campana, Maria Frigerio, Gianfranco Parati, Antonio Curnis, Irene Colangelo, Sergio Valsecchi

Published in: Trials | Issue 1/2009

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Abstract

Background

Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers.
Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier.

Methods

The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively.
Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink® monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations.

Trial registration

ClinicalTrials.gov: NCT00873899
Appendix
Available only for authorised users
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Metadata
Title
Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively
Authors
Maurizio Marzegalli
Maurizio Landolina
Maurizio Lunati
Giovanni B Perego
Alessia Pappone
Giuseppe Guenzati
Carlo Campana
Maria Frigerio
Gianfranco Parati
Antonio Curnis
Irene Colangelo
Sergio Valsecchi
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Trials / Issue 1/2009
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-10-42

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