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

April 1, 2009 updated by: Regione Lombardia
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Brescia, Italy, 25100
      • Milan, Italy, 20100
        • Enrolling by invitation
        • Azienda Ospedaliera Niguarda Ca' Granda
      • Milan, Italy, 20100
        • Enrolling by invitation
        • Azienda Ospedaliera San Carlo Borromeo
      • Milan, Italy, 20100
      • Milan, Italy, 20100
      • Pavia, Italy, 27100
        • Enrolling by invitation
        • IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with left ventricular systolic dysfunction implanted wih ICD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The rate of cardiac or device related clinic visits
Time Frame: 16 months
16 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regione Lombardia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Politecnico di Milano
Medtronic Italia
CEFRIEL, Milan Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RFPS-2006-2-335243-UO RL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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