Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
NCT ID: NCT00873899
Last Updated: 2009-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2008-05-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Remote Arm
The patients in Remote arm will receive a Medtronic CareLink Monitor to perform remote interrogation and transmission of ICD data. The remote arm ICD will be programmed to transmit over the CareLink Network.
The Medtronic CareLink system (Minneapolis, MN, USA).
The Medtronic CareLink system(Minneapolis, MN, USA)includes a patient monitor plugged into a standard analog telephone connection, and a lightweight wand to communicate with the implanted device. Interrogation of the device and transmission of the data occur when the patient places the wand over the implanted device. The system uses radio frequency telemetry for wireless automatic communication. This allows for data transmission without patient intervention and enables automatic transmissions at pre-specified routine intervals as well as alert-based downloads.The system can transmit data in case of programmable conditions on diagnostic variables, arrhythmias, delivered ICD therapies, battery/lead issues, and alert the physician via phone or e-mail. The patient's information is sent to a secure Network server via the telephone connection and clinical staff can review device information.Available data are equivalent to that which can be retrieved at an in-office visit.
Implantable defibrillator patients
Heart failure patients implanted with a wireless-transmission-enabled ICD.
The Medtronic CareLink system (Minneapolis, MN, USA).
The Medtronic CareLink system(Minneapolis, MN, USA)includes a patient monitor plugged into a standard analog telephone connection, and a lightweight wand to communicate with the implanted device. Interrogation of the device and transmission of the data occur when the patient places the wand over the implanted device. The system uses radio frequency telemetry for wireless automatic communication. This allows for data transmission without patient intervention and enables automatic transmissions at pre-specified routine intervals as well as alert-based downloads.The system can transmit data in case of programmable conditions on diagnostic variables, arrhythmias, delivered ICD therapies, battery/lead issues, and alert the physician via phone or e-mail. The patient's information is sent to a secure Network server via the telephone connection and clinical staff can review device information.Available data are equivalent to that which can be retrieved at an in-office visit.
Interventions
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The Medtronic CareLink system (Minneapolis, MN, USA).
The Medtronic CareLink system(Minneapolis, MN, USA)includes a patient monitor plugged into a standard analog telephone connection, and a lightweight wand to communicate with the implanted device. Interrogation of the device and transmission of the data occur when the patient places the wand over the implanted device. The system uses radio frequency telemetry for wireless automatic communication. This allows for data transmission without patient intervention and enables automatic transmissions at pre-specified routine intervals as well as alert-based downloads.The system can transmit data in case of programmable conditions on diagnostic variables, arrhythmias, delivered ICD therapies, battery/lead issues, and alert the physician via phone or e-mail. The patient's information is sent to a secure Network server via the telephone connection and clinical staff can review device information.Available data are equivalent to that which can be retrieved at an in-office visit.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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CEFRIEL, Milan Italy
UNKNOWN
Politecnico di Milano
OTHER
Medtronic Italia
INDUSTRY
Regione Lombardia
OTHER
Responsible Party
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Azienda Ospedaliera San Carlo Borromeo
Locations
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Azienda Ospedaliera Spedali Civili
Brescia, , Italy
Azienda Ospedaliera Niguarda Ca' Granda
Milan, , Italy
Azienda Ospedaliera San Carlo Borromeo
Milan, , Italy
IRCCS Auxologico Italiano Ospedale S. Luca
Milan, , Italy
IRCCS San Raffaele
Milan, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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RFPS-2006-2-335243-UO RL
Identifier Type: -
Identifier Source: org_study_id
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