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.
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.


BACKGROUND
ClinicalTrials.gov: NCT00873899.
Marzegalli
Maurizio
M
Cardiology Department, S, Carlo Borromeo Hospital, Milan, Italy. marzegalli.maurizio@sancarlo.mi.it
Landolina
Maurizio
M
Lunati
Maurizio
M
Perego
Giovanni B
GB
Pappone
Alessia
A
Guenzati
Giuseppe
G
Campana
Carlo
C
Frigerio
Maria
M
Parati
Gianfranco
G
Curnis
Antonio
A
Colangelo
Irene
I
Valsecchi
Sergio
S
D017147:Defibrillators, Implantable; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D020407:Internet; D019114:Remote Consultation / Q000379:methods* / Q000592:standards; D012107:Research Design; D018401:Sample Size; D014218:Triage / Q000379:methods* / Q000592:standards