Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients
Prospective Registry for the Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator (ICD) Recipients in the Clinical Practice
1 other identifier
observational
1,650
1 country
74
Brief Summary
The purpose of the registry is to evaluate an organizational model fixing roles and behaviors of subjects involved in the remote monitoring of patients implanted with pacemakers and defibrillators. The evaluation will estimate the clinical efficiency and the impact on health service resources of the organizational model when this is implemented in the daily clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Typical duration for all trials
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 28, 2013
March 1, 2013
3.8 years
October 24, 2011
March 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity, positive predictive value and expected utility of the organizational model
Sensitivity, positive predictive value and expected utility in the detection of all cardiovascular and device-related events of the proposed organizational model
Up to two years
Secondary Outcomes (1)
Manpower of the organizational model
Up to two years
Study Arms (1)
Cardiac Implantable Device recipients
Interventions
An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients
Eligibility Criteria
Cardiac Implantable Device recipients
You may qualify if:
- Patients implanted with a BIOTRONIK pacemaker or ICD with Home Monitoring (HM) technology
- Ability to utilize the HM system throughout the study
- Ability to give informed consent
- Ability to return for regular follow-ups for two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- San Filippo Neri General Hospitallead
- Biotronik Italiacollaborator
Study Sites (74)
Senigallia Civil Hospital
Senigallia, Ancona, Italy
Presidio Ospedale di Ariano Irpino
Ariano Irpino, Avellino, Italy
Umberto I Hospital
Altamura, Bari, Italy
Michele Sarcone Hospital
Terlizzi, Bari, Italy
PO Francesco Ferrari
Casarano, Lecce, Italy
P.O.G. Fogliani
Milazzo, Messina, Italy
Ospedale di Circolo
Desio, Monza E Brianza, Italy
San Leonardo
Castellammare di Stabia, Napoli, Italy
Volterra Hospital
Volterra, Pisa, Italy
SS. Cosimo e Damiano Hospital
Pescia, Pistoia, Italy
P. O. Villa D'Agri
Marsicovetere, Potenza, Italy
Guizzardi Hospital
Vittoria, Ragusa, Italy
G. B. Grassi
Ostia Antica, Roma, Italy
Santa Maria Della Misericordia Hospital
Sorrento, Salerno, Italy
P.O. Giannuzzi
Manduria, Taranto, Italy
Paolo Borsellino Hospital
Marsala, Trapani, Italy
Ulss n. 7
Conegliano, Treviso, Italy
Montebelluna Hospital
Montebelluna, Treviso, Italy
ULSS n. 14
Chioggia, Venezia, Italy
Dell'Angelo Hospital
Mestre, Venezia, Italy
Mirano Hospital
Mirano, Venezia, Italy
Portogruaro Hospital
Portogruaro, Venezia, Italy
Mater Salutis Hospital
Legnago, Verona, Italy
G.M. Lancisi Hospital
Ancona, Italy
I.N.R.C.A.
Ancona, Italy
S. Donato di Arezzo Hospital
Arezzo, Italy
Policlinico - Card. Universitaria
Bari, Italy
Policlinico - Cardiologia Ospedaliera
Bari, Italy
Policlinico - Cardiologia Ospedaliera
Benevento, Italy
AO Spedali Civili
Brescia, Italy
Congreg. Ancelle della Carità Poliambulanza
Brescia, Italy
A. Perrino Hospital
Brindisi, Italy
Cardarelli Hospital
Campobasso, Italy
S. Cuore University
Campobasso, Italy
Carrara Civil Hospital
Carrara, Italy
Sant'Anna e San Sebastiani Hospital
Caserta, Italy
Ferrarotto Hospital
Catania, Italy
AO Arcispedale S. Anna
Ferrara, Italy
A.O.U. Careggi S.O.D. Aritmologia
Florence, Italy
S. Giovanni di Dio Hospital
Florence, Italy
S. Maria Annunziata Hospital
Florence, Italy
S. Maria Nuova Hospital
Florence, Italy
P.O. Di Gorizia
Gorizia, Italy
F. Veneziale Hospital
Isernia, Italy
Vito Fazzi Hospital
Lecce, Italy
Piemonte Hospital
Messina, Italy
Sacco Hospital
Milan, Italy
F.B.F.
Napoli, Italy
Federico II Hospital
Napoli, Italy
Monaldi Hospital - Gruppo Sun
Napoli, Italy
Monaldi Hospital, U.O. Aritmologia
Napoli, Italy
Policlinico Federico II
Napoli, Italy
Policlinico Universitario di Padova
Padua, Italy
ARNAS Civico
Palermo, Italy
Cervello Hospital
Palermo, Italy
Santa Maria della Misericordia Hospital
Perugia, Italy
Guglielmo da Saliceto Civil Hospital
Piacenza, Italy
Santa Maria degli Angeli Hospital
Pordenone, Italy
Santa Maria Nuova Hospital
Reggio Emilia, Italy
Degli Infermi Hospital
Rimini, Italy
Casa di Cura Villa Pia
Roma, Italy
Policlinico Casilino
Roma, Italy
Policlinico Tor Vergata
Roma, Italy
Policlinico Umberto I
Roma, Italy
San Filippo Neri Hospital
Rome, Italy
San Giovanni di Dio e Ruggi D'Aragona Hospital
Salerno, Italy
San Donà di Piave Hospital
San Donà di Piave, Italy
Teresa Masselli Mascia Hospital
San Severo, Italy
P.O. SS. Annunziata
Taranto, Italy
Sant'Antonio Abate Hospital
Trapani, Italy
Ca' Foncello Hospital
Treviso, Italy
Di Circolo Hospital
Varese, Italy
Macchi Hospital
Varese, Italy
SS. Giovanni e Paolo Hospital
Venezia, Italy
Related Publications (1)
Ricci RP, Morichelli L, D'Onofrio A, Calo L, Vaccari D, Zanotto G, Curnis A, Buja G, Rovai N, Gargaro A. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry. Europace. 2013 Jul;15(7):970-7. doi: 10.1093/europace/eus440. Epub 2013 Jan 29.
PMID: 23362021RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato Pietro Ricci
San Filippo Neri Hospital, Rome, Italy
- STUDY CHAIR
Loredana Morichelli
San Filippo Neri Hospital, Rome, Italy
- STUDY CHAIR
Gianfranco Buja
Policlinico universitario, University of Padua, Italy
- STUDY CHAIR
Leonardo Calò
Policlinico Casilino, Rome, Italy
- STUDY CHAIR
Antonio Curnis
Spedali Civili, University of Brescia, Italy
- STUDY CHAIR
Antonio D'Onofrio
Monaldi Hospital, Italy
- STUDY CHAIR
Diego Vaccari
Montebelluna Hospital, Italy
- STUDY CHAIR
Gabriele Zanotto
Legnago Hospital, Verona, Italy
- STUDY CHAIR
Alessio Gargaro
Biotronik Italia
- STUDY CHAIR
Nicola Rovai
Biotronik Italia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 26, 2011
Study Start
March 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 28, 2013
Record last verified: 2013-03