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This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
Primary objective of the study is to observe how many of patients seen during these period (approximately 5000) will receive a change in cardiac device programming or in drug therapy or a scheduled or urgent hospital admission.
These data should help to clarify how useful and safe is a remote monitoring strategy for this kind of patients.
Number of Pacemakers (PM) and Implantable Cardioverter Defibrillators (ICD) is rapidly growing due to enlarged indications. This fact causes an exponential increase in scheduled in-hospital follow-ups. For this reason, all the companies that produce PM and ICD have released systems that allow remote monitoring and follow-up of cardiac devices (both PM and ICD) and U.S. guidelines have already been changed, in order to suggest remote follow-up of these devices at appropriated intervals.
Nevertheless, informations on actions taken during scheduled in-hospital follow-up are incomplete.
ATHENS study has been designed to answer to 3 questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac device | All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-hospital follow-up of cardiac device | Procedure | Electrical measures taken during normal follow-up and clinical status of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | 4 months | |
| Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who will undergo an in-hospital follow-up of a cardiac device
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| Name | Affiliation | Role |
|---|---|---|
| Giosue Mascioli, MD | Cliniche Humanitas Gavazzeni | Study Chair |
| Antonio Curnis, MD | Spedali Civili di Brescia | Study Chair |
| Maurizio Landolina, MD | Policlinico San Matteo Pavia | Principal Investigator |
| Gian-Paolo Gelmini, MD | Ospedale Civile di Desenzano d/Garda | Principal Investigator |
| Franco Ruffa, MD | Ospedale A. Manzoni - Lecco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Aritmologia - Cliniche Humanitas Gavazzeni | Bergamo | Bergamo | 24121 | Italy | ||
| Laboratorio di Elettrofisiologia - Spedali Civili |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15944090 | Background | Senges-Becker JC, Klostermann M, Becker R, Bauer A, Siegler KE, Katus HA, Schoels W. What is the "optimal" follow-up schedule for ICD patients? Europace. 2005 Jul;7(4):319-26. doi: 10.1016/j.eupc.2005.02.117. | |
| 15683509 | Background | Fauchier L, Sadoul N, Kouakam C, Briand F, Chauvin M, Babuty D, Clementy J. Potential cost savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2005 Jan;28 Suppl 1:S255-9. doi: 10.1111/j.1540-8159.2005.00071.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Device | All patients implanted with a cardiac device (PM or ICD) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Device | All patients implanted with a cardiac device (PM or ICD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | 2246 represents the number of patients in the whole population that were implanted with a PM | Posted | Number | 95% Confidence Interval | Participants | 4 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Device | All patients implanted with a cardiac device (PM or ICD) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Giosue Mascioli | Dept. of Arrhythmology - Cliniche Humanitas Gavazzeni | +39 035 4204159 | giosuemascioli@mac.com |
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| 4 months |
| Brescia |
| Brescia |
| 25123 |
| Italy |
| Laboratorio di Elettrofisiologia | Desenzano del Garda | Brescia | 25015 | Italy |
| Laboratorio di Cardiologia - Ospedale Civile | Casalmaggiore | Cremona | 26041 | Italy |
| Laboratorio di Elettrofisiologia - Ospedale A. Manzoni | Lecco | Lecco | 23900 | Italy |
| Laboratorio di Elettrofisiologia | Merate | Lecco | 23807 | Italy |
| Laboratorio di Elettrofisiologia - Ospedale Carlo Poma | Mantua | Mantova | 46100 | Italy |
| Laboratorio di Elettrofisiologia - Ospedale San Matteo | Pavia | Pavia | 27100 | Italy |
| 16598602 | Result | Brugada P. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up? Clin Res Cardiol. 2006;95 Suppl 3:III3-9. doi: 10.1007/s00392-006-1302-x. |
| 21764815 | Derived | Mascioli G, Curnis A, Landolina M, Klersy C, Gelmini GP, Ruffa F; ATHENS Investigators. Actions elicited during scheduled and unscheduled in-hospital follow-up of cardiac devices: results of the ATHENS multicentre registry. Europace. 2011 Dec;13(12):1766-73. doi: 10.1093/europace/eur233. Epub 2011 Jul 14. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | Posted | Number | 95% Confidence Interval | Participants | 4 months |
|
|
|
| Secondary | Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | 693 represents the number of patients implanted with an ICD within the whole population | Posted | Number | 95% Confidence Interval | Participants | 4 months |
|
|
|
| 0 |
| 3,362 |
| 0 |
| 3,362 |
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