Clinical trial NCT00873899: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Sudden Cardiac Death
Implantable Defibrillator
Keywords: Heart Failure
Implantable defibrillator
Remote Monitoring
Lead sponsor: Regione Lombardia
Sponsor class: OTHER
Collaborators: name: CEFRIEL, Milan Italy
name: Politecnico di Milano
name: Medtronic Italia
First posted: 2009-04-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with left ventricular systolic dysfunction implanted wih ICD

Brief summary: The EVOLVO study is designed to compare the remote defibrillator management to the current standard of care, to assess its ability to treat and triage patients more effectively.

Detailed description: Heart failure patients with implantable defibrillators (ICD) perform frequent clinic visits for routine device monitoring. Moreover, in 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 create a great burden on healthcare providers. Internet-based remote device interrogation systems, allowing physician's remote access to patients' data, are being proposed for reducing routine and interim visits and for earlier detection and notification of alert conditions.

Eligibility criteria: Inclusion Criteria:

* Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤35%, as documented at the moment of ICD implant;
* Patient implanted with a wireless-transmission-enabled Medtronic ICD or CRT-D;
* Patient must be able and willing to replace regularly-scheduled in-office routine follow-ups with remote follow-ups;
* Patient must be able to attend all required follow-up visits at the study center.

Exclusion Criteria:

* Patient is less than 18 years of age;
* Patient is unwilling or unable to sign an informed consent;
* Patient life expectancy is less than 12 months;
* Patient is participating in another clinical study that may have an impact on the study endpoints.

Primary outcomes:
measure: The rate of cardiac or device related clinic visits
timeFrame: 16 months
Secondary outcomes:
measure: Rate of visits related or not to episodes of worsening of heart failure. Rate and related costs of total health care utilizations (all planned and unplanned hospital admissions involving and not an overnight stay) for cardiac or device related events
timeFrame: one year
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili
city: Milan
country: Italy
facility: Azienda Ospedaliera Niguarda Ca' Granda
city: Milan
country: Italy
facility: Azienda Ospedaliera San Carlo Borromeo
city: Milan
country: Italy
facility: IRCCS Auxologico Italiano Ospedale S. Luca
city: Milan
country: Italy
facility: IRCCS San Raffaele
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
References:
citation: Zanaboni P, Landolina M, Marzegalli M, Lunati M, Perego GB, Guenzati G, Curnis A, Valsecchi S, Borghetti F, Borghi G, Masella C. Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial. J Med Internet Res. 2013 May 30;15(5):e106. doi: 10.2196/jmir.2587.
citation: Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
citation: Marzegalli M, Landolina M, Lunati M, Perego GB, Pappone A, Guenzati G, Campana C, Frigerio M, Parati G, Curnis A, Colangelo I, Valsecchi S. 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. Trials. 2009 Jun 18;10:42. doi: 10.1186/1745-6215-10-42.