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

Regione Lombardia

Status: Unknown

Conditions: Implantable Defibrillator; Heart Failure; Sudden Cardiac Death

Treatments: Device: The Medtronic CareLink system (Minneapolis, MN, USA).

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00873899

RFPS-2006-2-335243-UO RL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Remote Arm

Description:

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.

Treatment:

Device: The Medtronic CareLink system (Minneapolis, MN, USA).

Implantable defibrillator patients

Description:

Heart failure patients implanted with a wireless-transmission-enabled ICD.

Treatment:

Device: The Medtronic CareLink system (Minneapolis, MN, USA).