Heart FailureEVOLVONCT00873899
Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
An observational study of Heart Failure and Sudden Cardiac Death, run by Regione Lombardia at 6 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Sudden Cardiac Death, Implantable Defibrillator
- What is being tested?
- The Medtronic CareLink system (Minneapolis, MN, USA).
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesItaly
- Study dates
- May 2008to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with left ventricular systolic dysfunction implanted wih ICD
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
Azienda Ospedaliera Spedali Civili
Brescia, 25100
Antonio Curnis, antonio.curnis@libero.it
- Enrolling by invitation
Azienda Ospedaliera Niguarda Ca' Granda
Milan, 20100
- Enrolling by invitation
Azienda Ospedaliera San Carlo Borromeo
Milan, 20100
- Recruiting
IRCCS Auxologico Italiano Ospedale S. Luca
Milan, 20100
Giovanni B. Perego, perego@auxologico.it
Giancarlo Parati, gianfranco.parati@unimib.it
- Not yet recruiting
IRCCS San Raffaele
Milan, 20100
Alessia Pappone, pappone.alessia@hsr.it
- Enrolling by invitation
IRCCS Policlinico San Matteo
Pavia, 27100
About this study
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.
Read the 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.
- Being tested
- The Medtronic CareLink system (Minneapolis, MN, USA).
- Keywords
- Heart Failure, Implantable defibrillator, Remote Monitoring
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: The Medtronic CareLink system (Minneapolis, MN, USA). | |
| Implantable defibrillator patients | Heart failure patients implanted with a wireless-transmission-enabled ICD. Receives: Device: The Medtronic CareLink system (Minneapolis, MN, USA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of cardiac or device related clinic visits
Measured: 16 months
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMay 2008
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regione Lombardia
- Sponsor type
- University, hospital or other
- Collaborators
- CEFRIEL, Milan Italy, Politecnico di Milano, Medtronic Italia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873899
- Sponsor's protocol ID
- RFPS-2006-2-335243-UO RL
- Acronym
- EVOLVO
- Status last verified
- Apr 2009
- First submitted
- 1 Apr 2009
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Zanaboni P, Landolina M, Marzegalli M, Lunati M, Perego GB, Guenzati G, Curnis A, Valsecchi S, Borghetti F, Borghi G, Masella C. Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial. J Med Internet Res. 2013 May 30;15(5):e106. doi: 10.2196/jmir.2587.
PubMed 23722666Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
PubMed 22626743Marzegalli M, Landolina M, Lunati M, Perego GB, Pappone A, Guenzati G, Campana C, Frigerio M, Parati G, Curnis A, Colangelo I, Valsecchi S. Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively. Trials. 2009 Jun 18;10:42. doi: 10.1186/1745-6215-10-42.
PubMed 19538734
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators
- ClinicalTrials.gov ID
- NCT00873899
- Acronym / sponsor ID
- EVOLVO / RFPS-2006-2-335243-UO RL
- Keywords
- Heart Failure, Implantable defibrillator, Remote Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Regione LombardiaUniversity, hospital or other
- Collaborators
- CEFRIEL, Milan Italy, Politecnico di Milano, Medtronic Italia
- Study start
- May 2008
- Study completion
- Sep 2010 (estimated)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Arm | – | Device: The Medtronic CareLink system (Minneapolis, MN, USA).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. |
| Implantable defibrillator patients | – | Device: The Medtronic CareLink system (Minneapolis, MN, USA).Heart failure patients implanted with a wireless-transmission-enabled ICD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with left ventricular systolic dysfunction implanted wih ICD
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Implantable defibrillator patients, Remote Arm |
Primary outcome
The rate of cardiac or device related clinic visits
Time frame: 16 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2009.
- Derived from this study: PubMed 23722666Zanaboni P, Landolina M, Marzegalli M, Lunati M, Perego GB, Guenzati G, Curnis A, Valsecchi S, Borghetti F, Borghi G, Masella C. Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial. J Med Internet Res. 2013 May 30;15(5):e106. doi: 10.2196/jmir.2587.
- Derived from this study: PubMed 22626743Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation. 2012 Jun 19;125(24):2985-92. doi: 10.1161/CIRCULATIONAHA.111.088971. Epub 2012 May 24.
- Derived from this study: PubMed 19538734Marzegalli M, Landolina M, Lunati M, Perego GB, Pappone A, Guenzati G, Campana C, Frigerio M, Parati G, Curnis A, Colangelo I, Valsecchi S. Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively. Trials. 2009 Jun 18;10:42. doi: 10.1186/1745-6215-10-42.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sudden Cardiac Death, run by Regione Lombardia at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Marzegalli (+390240222312, marzegalli.maurizio@sancarlo.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of cardiac or device related clinic visits (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00873899, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2009.