Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
EVOLVO
1 other identifier
observational
200
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 2, 2009
April 1, 2009
April 1, 2009
April 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of cardiac or device related clinic visits
16 months
Secondary Outcomes (1)
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
one year
Study Arms (2)
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.
Implantable defibrillator patients
Heart failure patients implanted with a wireless-transmission-enabled ICD.
Interventions
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
Patient with left ventricular systolic dysfunction implanted wih ICD
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regione Lombardialead
- CEFRIEL, Milan Italycollaborator
- Politecnico di Milanocollaborator
- Medtronic Italiacollaborator
Study Sites (6)
Azienda Ospedaliera Spedali Civili
Brescia, 25100, Italy
Azienda Ospedaliera Niguarda Ca' Granda
Milan, 20100, Italy
Azienda Ospedaliera San Carlo Borromeo
Milan, 20100, Italy
IRCCS Auxologico Italiano Ospedale S. Luca
Milan, 20100, Italy
IRCCS San Raffaele
Milan, 20100, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Related Publications (3)
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.
PMID: 23722666DERIVEDLandolina 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.
PMID: 22626743DERIVEDMarzegalli 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.
PMID: 19538734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 2, 2009
Study Start
May 1, 2008
Study Completion
September 1, 2010
Last Updated
April 2, 2009
Record last verified: 2009-04