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Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Regione Lombardia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
CEFRIEL, Milan Italy
Politecnico di Milano
Medtronic Italia
Information provided by:
Regione Lombardia
ClinicalTrials.gov Identifier:
NCT00873899
First received: April 1, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 1, 2009
April 1, 2009
May 2008
Not Provided
The rate of cardiac or device related clinic visits [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
Not Provided

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patient with left ventricular systolic dysfunction implanted wih ICD

  • Heart Failure
  • Sudden Cardiac Death
  • Implantable Defibrillator
Device: 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.
  • 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.
    Intervention: Device: The Medtronic CareLink system (Minneapolis, MN, USA).
  • Implantable defibrillator patients
    Heart failure patients implanted with a wireless-transmission-enabled ICD.
    Intervention: Device: The Medtronic CareLink system (Minneapolis, MN, USA).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 2010
Not Provided

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.
Both
18 Years and older
No
Contact: Maurizio Marzegalli +390240222312 marzegalli.maurizio@sancarlo.mi.it
Italy
 
NCT00873899
RFPS-2006-2-335243-UO RL
No
Maurizio Marzegalli - Direttore Dipartimento DEA e UO Cardiologia, Azienda Ospedaliera San Carlo Borromeo
Regione Lombardia
  • CEFRIEL, Milan Italy
  • Politecnico di Milano
  • Medtronic Italia
Not Provided
Regione Lombardia
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP