Status:
UNKNOWN
Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
Lead Sponsor:
Regione Lombardia
Collaborating Sponsors:
CEFRIEL, Milan Italy
Politecnico di Milano
Conditions:
Heart Failure
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
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 notificatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00873899
Start Date
May 1 2008
End Date
September 1 2010
Last Update
April 2 2009
Active Locations (6)
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1
Azienda Ospedaliera Spedali Civili
Brescia, Italy, 25100
2
Azienda Ospedaliera Niguarda Ca' Granda
Milan, Italy, 20100
3
Azienda Ospedaliera San Carlo Borromeo
Milan, Italy, 20100
4
IRCCS Auxologico Italiano Ospedale S. Luca
Milan, Italy, 20100