Cardiac Pacemaker, ArtificialATHENSNCT01073449
Actions Elicited by In-hospital Follow-up of Cardiac Devices
An observational study of Cardiac Pacemaker, Artificial and Implantable Cardioverter-Defibrillator, run by Cliniche Humanitas Gavazzeni at 8 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillator
- What is being tested?
- In-hospital follow-up of cardiac device
- Type of treatment
- Surgery or procedure
- How many people
- 3,362 participants
- Where
- 8 sitesItaly
- Study dates
- Feb 2010to Jan 2011
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who will undergo an in-hospital follow-up of a cardiac device
Who may be able to join
- All patients with a cardiac device
Who cannot join
- Follow-up of a cardiac device at discharge from hospital after first implant
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
U.O. Aritmologia - Cliniche Humanitas Gavazzeni
Bergamo, Bergamo, 24121
Laboratorio di Elettrofisiologia - Spedali Civili
Brescia, Brescia, 25123
Laboratorio di Cardiologia - Ospedale Civile
Casalmaggiore, Cremona, 26041
Laboratorio di Elettrofisiologia
Desenzano del Garda, Brescia, 25015
Laboratorio di Elettrofisiologia - Ospedale A. Manzoni
Lecco, Lecco, 23900
Laboratorio di Elettrofisiologia - Ospedale Carlo Poma
Mantua, Mantova, 46100
Laboratorio di Elettrofisiologia
Merate, Lecco, 23807
Laboratorio di Elettrofisiologia - Ospedale San Matteo
Pavia, Pavia, 27100
About this study
Official title: Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices
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.
Read the 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:
- How often, during a scheduled in hospital follow-up physicians "change" something ? (device programming; drug therapy; scheduled device replacement ...)
- 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?
- Change are more frequent during PM or during ICD follow-up or during cardiac resynchronization therapy devices?
- Being tested
- In-hospital follow-up of cardiac device
- Keywords
- Cardiac devices, In-Hospital Follow-up, Analytical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-hospital follow-up of cardiac deviceProcedure or surgery
Electrical measures taken during normal follow-up and clinical status of the patient
| Study group | Role | What they receive |
|---|---|---|
| Cardiac device | All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD) Receives: Procedure: In-hospital follow-up of cardiac device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
Measured: 4 months
Secondary outcomes (2)
Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Pacemaker, ArtificialStudies 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
- 3,362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniche Humanitas Gavazzeni
- Sponsor type
- University, hospital or other
- Investigators
- Giosue Mascioli, MD, Study chair, Cliniche Humanitas GavazzeniAntonio Curnis, MD, Study chair, Spedali Civili di BresciaMaurizio Landolina, MD, Principal investigator, Policlinico San Matteo PaviaGian-Paolo Gelmini, MD, Principal investigator, Ospedale Civile di Desenzano d/GardaFranco Ruffa, MD, Principal investigator, Ospedale A. Manzoni - Lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073449
- Sponsor's protocol ID
- GAVBS1
- Acronym
- ATHENS
- Status last verified
- Jan 2011
- First submitted
- 22 Feb 2010
- Last updated
- 28 Feb 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15944090Fauchier 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.
PubMed 15683509Brugada 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.
PubMed 16598602Mascioli 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.
PubMed 21764815