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| Name | Class |
|---|---|
| Biotronik Italia | INDUSTRY |
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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.
After a number of studies which assessed technical reliability and clinical implications of remote monitoring systems, a further step should approach the issue of how remote monitoring can be implemented as a part of routine activities of a cardiology outpatient clinic. A clear definition of roles and workflow to timely manage information and properly react to adverse events is required. The HomeGuide Registry proposes an organizational model specifying roles and procedures for outpatient clinics using a specific remote monitoring system in routine follow-up. The HomeGuide model is essentially based on an interaction between one or more allied professionals (expert and trained nurses or technicians) and a responsible physician. The main objective of the HomeGuide Registry is to evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Implantable Device recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organizational model for remote monitoring | Behavioral | An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Manpower of the organizational model | Health care source consumption required to implement the organizational model for the remote management of patients | Up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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Cardiac Implantable Device recipients
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| Name | Affiliation | Role |
|---|---|---|
| Renato Pietro Ricci | San Filippo Neri Hospital, Rome, Italy | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senigallia Civil Hospital | Senigallia | Ancona | Italy | |||
| Presidio Ospedale di Ariano Irpino |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23362021 | Result | 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. |
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|
| Biotronik Italia |
| Study Chair |
| 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. | Naples | Italy |
| Federico II Hospital | Naples | Italy |
| Monaldi Hospital - Gruppo Sun | Naples | Italy |
| Monaldi Hospital, U.O. Aritmologia | Naples | Italy |
| Policlinico Federico II | Naples | Italy |
| Policlinico Universitario di Padova | Padova | 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 |
| ID | Term |
|---|---|
| D017146 | Models, Organizational |
| ID | Term |
|---|---|
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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