Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators - Full Text View

Sponsors and Collaborators:	Regione Lombardia CEFRIEL, Milan Italy Politecnico di Milano, Department of Management, Economics and Industrial Engineering, Milan Italy Medtronic Italia, Milan Italy
Information provided by:	Regione Lombardia
ClinicalTrials.gov Identifier:	NCT00873899

Purpose

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.

Condition	Intervention
Heart Failure Sudden Cardiac Death Implantable Defibrillator	Device: The Medtronic CareLink system (Minneapolis, MN, USA).

MedlinePlus related topics: Cardiac Arrest Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Regione Lombardia:

Primary Outcome Measures:

The rate of cardiac or device related clinic visits [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2010

Groups/Cohorts	Assigned Interventions
Remote Arm 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.	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.
Implantable defibrillator patients Heart failure patients implanted with a wireless-transmission-enabled ICD.	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.

Groups/Cohorts

Assigned Interventions

Remote Arm

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.

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.

Implantable defibrillator patients

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

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient with left ventricular systolic dysfunction implanted wih ICD

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873899

Contacts

Contact: Maurizio Marzegalli

+390240222312

marzegalli.maurizio@sancarlo.mi.it

Locations

Italy
Azienda Ospedaliera San Carlo Borromeo	Enrolling by invitation
Milan, Italy, 20100
Azienda Ospedaliera Niguarda Ca' Granda	Enrolling by invitation
Milan, Italy, 20100
IRCCS Auxologico Italiano Ospedale S. Luca	Recruiting
Milan, Italy, 20100
Contact: Giovanni B. Perego perego@auxologico.it
Contact: Giancarlo Parati gianfranco.parati@unimib.it
Azienda Ospedaliera Spedali Civili	Recruiting
Brescia, Italy, 25100
Contact: Antonio Curnis antonio.curnis@libero.it
IRCCS Policlinico San Matteo	Enrolling by invitation
Pavia, Italy, 27100
IRCCS San Raffaele	Not yet recruiting
Milan, Italy, 20100
Contact: Alessia Pappone pappone.alessia@hsr.it

Sponsors and Collaborators

Regione Lombardia

CEFRIEL, Milan Italy

Politecnico di Milano, Department of Management, Economics and Industrial Engineering, Milan Italy

Medtronic Italia, Milan Italy

More Information

Additional Information:

Click here for more information about this study:" : Evolution of Management Strategies of Heart Failure Patients with Implantable Defibrillators (EVOLVO) (Web site in Italian) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Azienda Ospedaliera San Carlo Borromeo ( Maurizio Marzegalli - Direttore Dipartimento DEA e UO Cardiologia )
Study ID Numbers:	RFPS-2006-2-335243-UO RL
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00873899 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Regione Lombardia:

Heart Failure
Implantable defibrillator
Remote Monitoring

Study placed in the following topic categories:

Death
Heart Failure
Heart Diseases

Death, Sudden
Heart Arrest
Death, Sudden, Cardiac

Additional relevant MeSH terms:

Death
Heart Failure
Pathologic Processes
Heart Diseases

Death, Sudden
Heart Arrest
Cardiovascular Diseases
Death, Sudden, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009