Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators

Regione Lombardia200 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Heart Failure Sudden Cardiac Death Implantable Defibrillator

Interventions

The Medtronic CareLink system (Minneapolis, MN, USA).DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Azienda Ospedaliera Spedali Civili

Brescia, Italy

RECRUITING

Azienda Ospedaliera Niguarda Ca' Granda

Milan, Italy

ENROLLING_BY_INVITATION

Azienda Ospedaliera San Carlo Borromeo

Milan, Italy

Outcomes

Primary Outcomes

The rate of cardiac or device related clinic visits

Time frame: 16 months

Secondary Outcomes

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

Central Contacts

Maurizio Marzegalli

CONTACT

+390240222312 marzegalli.maurizio@sancarlo.mi.it

Data from ClinicalTrials.gov

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