Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators

Heart Failure Clinical Trial

— EVOLVO  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00873899
• Other study ID #: RFPS-2006-2-335243-UO RL
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2009
• Last updated: April 1, 2009
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: April 2009
• Source: Regione Lombardia
• Contact: Maurizio Marzegalli
• Phone: +390240222312
• Email: marzegalli.maurizio[@]sancarlo.mi.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Failure
• Implantable Defibrillator
• Sudden Cardiac Death

Intervention

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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Spedali Civili	Brescia
Italy	Azienda Ospedaliera Niguarda Ca' Granda	Milan
Italy	Azienda Ospedaliera San Carlo Borromeo	Milan
Italy	IRCCS Auxologico Italiano Ospedale S. Luca	Milan
Italy	IRCCS San Raffaele	Milan
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (4)

Lead Sponsor	Collaborator
Regione Lombardia	CEFRIEL, Milan Italy, Medtronic Italia, Politecnico di Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of cardiac or device related clinic visits		16 months	No
Secondary	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	No