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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Regione Lombardia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
CEFRIEL, Milan Italy
Politecnico di Milano
Medtronic Italia
Information provided by:
Regione Lombardia
ClinicalTrials.gov Identifier:
NCT00873899
First received: April 1, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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).

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


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 ]

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Spedali Civili Recruiting
Brescia, Italy, 25100
Contact: Antonio Curnis       antonio.curnis@libero.it   
Azienda Ospedaliera Niguarda Ca' Granda Enrolling by invitation
Milan, Italy, 20100
Azienda Ospedaliera San Carlo Borromeo 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   
IRCCS San Raffaele Not yet recruiting
Milan, Italy, 20100
Contact: Alessia Pappone       pappone.alessia@hsr.it   
IRCCS Policlinico San Matteo Enrolling by invitation
Pavia, Italy, 27100
Sponsors and Collaborators
Regione Lombardia
CEFRIEL, Milan Italy
Politecnico di Milano
Medtronic Italia
  More Information

No publications provided by Regione Lombardia

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

Keywords provided by Regione Lombardia:
Heart Failure
Implantable defibrillator
Remote Monitoring

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Heart Failure
Cardiovascular Diseases
Death
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014