Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients
NCT ID: NCT01459874
Last Updated: 2013-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1650 participants
OBSERVATIONAL
2008-03-31
2011-12-31
Brief Summary
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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.
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Detailed Description
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1. Clinical efficiency of remote patient management;
2. Health service resources required by a remote patient management.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cardiac Implantable Device recipients
Organizational model for remote monitoring
An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients
Interventions
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Organizational model for remote monitoring
An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to utilize the HM system throughout the study
* Ability to give informed consent
* Ability to return for regular follow-ups for two years
ALL
No
Sponsors
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Biotronik Italia
INDUSTRY
San Filippo Neri General Hospital
OTHER
Responsible Party
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Renato Pietro Ricci
Principal Investigator
Principal Investigators
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Renato Pietro Ricci
Role: PRINCIPAL_INVESTIGATOR
San Filippo Neri Hospital, Rome, Italy
Loredana Morichelli
Role: STUDY_CHAIR
San Filippo Neri Hospital, Rome, Italy
Gianfranco Buja
Role: STUDY_CHAIR
Policlinico universitario, University of Padua, Italy
Leonardo Calò
Role: STUDY_CHAIR
Policlinico Casilino, Rome, Italy
Antonio Curnis
Role: STUDY_CHAIR
Spedali Civili, University of Brescia, Italy
Antonio D'Onofrio
Role: STUDY_CHAIR
Monaldi Hospital, Italy
Diego Vaccari
Role: STUDY_CHAIR
Montebelluna Hospital, Italy
Gabriele Zanotto
Role: STUDY_CHAIR
Legnago Hospital, Verona, Italy
Alessio Gargaro
Role: STUDY_CHAIR
Biotronik Italia
Nicola Rovai
Role: STUDY_CHAIR
Biotronik Italia
Locations
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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
Countries
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References
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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.
Other Identifiers
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HomeGuide
Identifier Type: -
Identifier Source: org_study_id
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