Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators

NCT00873899 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2009-04-02

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • CEFRIEL, Milan Italy

    collaborator UNKNOWN
  • Politecnico di Milano

    collaborator OTHER
  • Medtronic Italia

    collaborator INDUSTRY
  • Regione Lombardia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Completion
2010-09-30

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873899 on ClinicalTrials.gov