Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillator
Conditions
Keywords
Cardiac devices, In-Hospital Follow-up, Analytical
Brief summary
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.
Detailed description
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: 1. How often, during a scheduled in hospital follow-up physicians change something ? (device programming; drug therapy; scheduled device replacement ...) 2. The rate of change is different is the follow-up is required pby the general practitioner who normally takes care of the patients or by the patient itself? 3. Change are more frequent during PM or during ICD follow-up or during cardiac resynchronization therapy devices?
Interventions
PROCEDUREIn-hospital follow-up of cardiac device
Electrical measures taken during normal follow-up and clinical status of the patient
Sponsors
Cliniche Humanitas Gavazzeni
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients with a cardiac device
Exclusion criteria
* Follow-up of a cardiac device at discharge from hospital after first implant
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 4 months |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Device All patients implanted with a cardiac device (PM or ICD) | 3,362 |
| Total | 3,362 |
Baseline characteristics
| Characteristic | Cardiac Device |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 2718 Participants |
| Age, Categorical Between 18 and 65 years | 640 Participants |
| Age Continuous | 73.36 years STANDARD_DEVIATION 12.16 |
| Region of Enrollment Italy | 3362 participants |
| Sex: Female, Male Female | 1156 Participants |
| Sex: Female, Male Male | 2206 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,362 |
| serious Total, serious adverse events | 0 / 3,362 |
Outcome results
Primary
Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Device | Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | 767 Participants |
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
Time frame: 4 months
Population: 693 represents the number of patients implanted with an ICD within the whole population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Device | 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 | 129 Participants |
Secondary
Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
Time frame: 4 months
Population: 2246 represents the number of patients in the whole population that were implanted with a PM
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Device | Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up | 512 Participants |