Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators

• Conditions: Heart Failure; Sudden Cardiac Death; Implantable Defibrillator
• Interventions: Device: The Medtronic CareLink system (Minneapolis, MN, USA).

• Registration Number: NCT00873899
• Lead Sponsor: Regione Lombardia

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 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.

Study Timeline

• Study Start: 2008-05
• Status Verified: 2009-04
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Last Update Submitted: 2009-04-01
• Study First Posted: 2009-04-02
• Last Update Posted: 2009-04-02
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remote Arm	The Medtronic CareLink system (Minneapolis, MN, USA).	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	The Medtronic CareLink system (Minneapolis, MN, USA).	Heart failure patients implanted with a wireless-transmission-enabled ICD.

Primary Outcome Measures

Name	Time	Method
The rate of cardiac or device related clinic visits	16 months

Secondary Outcome Measures

Name	Time	Method
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	one year

Trial Locations

Locations (6)

Azienda Ospedaliera San Carlo Borromeo; 🇮🇹 Milan, Italy

IRCCS Auxologico Italiano Ospedale S. Luca; 🇮🇹 Milan, Italy

IRCCS San Raffaele; 🇮🇹 Milan, Italy

Azienda Ospedaliera Spedali Civili; 🇮🇹 Brescia, Italy

Azienda Ospedaliera Niguarda Ca' Granda; 🇮🇹 Milan, Italy

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy