Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of cardiac or device related clinic visits
    • Time Frame: 16 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regione Lombardia
  • Collaborator
    • CEFRIEL, Milan Italy
  • Provider of Information About this Clinical Study
    • Maurizio Marzegalli – Direttore Dipartimento DEA e UO Cardiologia, Azienda Ospedaliera San Carlo Borromeo
  • Overall Contact(s)
    • Maurizio Marzegalli, +390240222312, marzegalli.maurizio@sancarlo.mi.it

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