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| Name | Class |
|---|---|
| CEFRIEL, Milan Italy | UNKNOWN |
| Politecnico di Milano | OTHER |
| Medtronic Italia | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Implantable defibrillator patients | Heart failure patients implanted with a wireless-transmission-enabled ICD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of cardiac or device related clinic visits | 16 months |
| Measure | Description | 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 | one year |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with left ventricular systolic dysfunction implanted wih ICD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maurizio Marzegalli | Contact | +390240222312 | marzegalli.maurizio@sancarlo.mi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Spedali Civili | Recruiting | Brescia | 25100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23722666 | Derived | 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. | |
| 22626743 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
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|
| Azienda Ospedaliera Niguarda Ca' Granda | Enrolling by invitation | Milan | 20100 | Italy |
| Azienda Ospedaliera San Carlo Borromeo | Enrolling by invitation | Milan | 20100 | Italy |
| IRCCS Auxologico Italiano Ospedale S. Luca | Recruiting | Milan | 20100 | Italy |
|
| IRCCS San Raffaele | Not yet recruiting | Milan | 20100 | Italy |
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| IRCCS Policlinico San Matteo | Enrolling by invitation | Pavia | 27100 | Italy |
| Landolina 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. |
| 19538734 | Derived | Marzegalli 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. |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |