Clinical trial NCT01459874: Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients
Official title: Prospective Registry for the Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator (ICD) Recipients in the Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
Implantable Cardioverter Defibrillator
Keywords: Home Monitoring
Remote monitoring
Telecardiology
Organizational model
Patient indicated for pacemaker, ICD, CRT-P, or CRT-D
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
Collaborators: name: Biotronik Italia
First posted: 2011-10-26
Enrollment: 1650
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac Implantable Device recipients

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.

Detailed description: 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:

1. Clinical efficiency of remote patient management;
2. Health service resources required by a remote patient management.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who do not fulfill all inclusion criteria

Primary outcomes:
measure: Sensitivity, positive predictive value and expected utility of the organizational model
timeFrame: Up to two years
Secondary outcomes:
measure: Manpower of the organizational model
timeFrame: Up to two years
Other outcomes:
Locations:
city: Senigallia
country: Italy
facility: Senigallia Civil Hospital
state: Ancona
city: Ariano Irpino
country: Italy
facility: Presidio Ospedale di Ariano Irpino
state: Avellino
city: Altamura
country: Italy
facility: Umberto I Hospital
state: Bari
city: Terlizzi
country: Italy
facility: Michele Sarcone Hospital
state: Bari
city: Casarano
country: Italy
facility: PO Francesco Ferrari
state: Lecce
city: Milazzo
country: Italy
facility: P.O.G. Fogliani
state: Messina
city: Desio
country: Italy
facility: Ospedale di Circolo
state: Monza e Brianza
city: Castellammare di Stabia
country: Italy
facility: San Leonardo
state: Napoli
city: Volterra
country: Italy
facility: Volterra Hospital
state: Pisa
city: Pescia
country: Italy
facility: SS. Cosimo e Damiano Hospital
state: Pistoia
city: Marsicovetere
country: Italy
facility: P. O. Villa D'Agri
state: Potenza
city: Vittoria
country: Italy
facility: Guizzardi Hospital
state: Ragusa
city: Ostia
country: Italy
facility: G. B. Grassi
state: Roma
city: Sorrento
country: Italy
facility: Santa Maria Della Misericordia Hospital
state: Salerno
city: Manduria
country: Italy
facility: P.O. Giannuzzi
state: Taranto
city: Marsala
country: Italy
facility: Paolo Borsellino Hospital
state: Trapani
city: Conegliano
country: Italy
facility: Ulss n. 7
state: Treviso
city: Montebelluna
country: Italy
facility: Montebelluna Hospital
state: Treviso
city: Chioggia
country: Italy
facility: ULSS n. 14
state: Venezia
city: Mestre
country: Italy
facility: Dell'Angelo Hospital
state: Venezia
city: Mirano
country: Italy
facility: Mirano Hospital
state: Venezia
city: Portogruaro
country: Italy
facility: Portogruaro Hospital
state: Venezia
city: Legnago
country: Italy
facility: Mater Salutis Hospital
state: Verona
city: Ancona
country: Italy
facility: G.M. Lancisi Hospital
city: Ancona
country: Italy
facility: I.N.R.C.A.
city: Arezzo
country: Italy
facility: S. Donato di Arezzo Hospital
city: Bari
country: Italy
facility: Policlinico - Card. Universitaria
city: Bari
country: Italy
facility: Policlinico - Cardiologia Ospedaliera
city: Benevento
country: Italy
facility: Policlinico - Cardiologia Ospedaliera
city: Brescia
country: Italy
facility: AO Spedali Civili
city: Brescia
country: Italy
facility: Congreg. Ancelle della Carità Poliambulanza
city: Brindisi
country: Italy
facility: A. Perrino Hospital
city: Campobasso
country: Italy
facility: Cardarelli Hospital
city: Campobasso
country: Italy
facility: S. Cuore University
city: Carrara
country: Italy
facility: Carrara Civil Hospital
city: Caserta
country: Italy
facility: Sant'Anna e San Sebastiani Hospital
city: Catania
country: Italy
facility: Ferrarotto Hospital
city: Ferrara
country: Italy
facility: AO Arcispedale S. Anna
city: Firenze
country: Italy
facility: A.O.U. Careggi S.O.D. Aritmologia
city: Firenze
country: Italy
facility: S. Giovanni di Dio Hospital
city: Firenze
country: Italy
facility: S. Maria Annunziata Hospital
city: Firenze
country: Italy
facility: S. Maria Nuova Hospital
city: Gorizia
country: Italy
facility: P.O. Di Gorizia
city: Isernia
country: Italy
facility: F. Veneziale Hospital
city: Lecce
country: Italy
facility: Vito Fazzi Hospital
city: Messina
country: Italy
facility: Piemonte Hospital
city: Milano
country: Italy
facility: Sacco Hospital
city: Napoli
country: Italy
facility: F.B.F.
city: Napoli
country: Italy
facility: Federico II Hospital
city: Napoli
country: Italy
facility: Monaldi Hospital - Gruppo Sun
city: Napoli
country: Italy
facility: Monaldi Hospital, U.O. Aritmologia
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Padova
country: Italy
facility: Policlinico Universitario di Padova
city: Palermo
country: Italy
facility: ARNAS Civico
city: Palermo
country: Italy
facility: Cervello Hospital
city: Perugia
country: Italy
facility: Santa Maria della Misericordia Hospital
city: Piacenza
country: Italy
facility: Guglielmo da Saliceto Civil Hospital
city: Pordenone
country: Italy
facility: Santa Maria degli Angeli Hospital
city: Reggio Emilia
country: Italy
facility: Santa Maria Nuova Hospital
city: Rimini
country: Italy
facility: Degli Infermi Hospital
city: Roma
country: Italy
facility: Casa di Cura Villa Pia
city: Roma
country: Italy
facility: Policlinico Casilino
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: San Filippo Neri Hospital
city: Salerno
country: Italy
facility: San Giovanni di Dio e Ruggi D'Aragona Hospital
city: San Donà di Piave
country: Italy
facility: San Donà di Piave Hospital
city: San Severo
country: Italy
facility: Teresa Masselli Mascia Hospital
city: Taranto
country: Italy
facility: P.O. SS. Annunziata
city: Trapani
country: Italy
facility: Sant'Antonio Abate Hospital
city: Treviso
country: Italy
facility: Ca' Foncello Hospital
city: Varese
country: Italy
facility: Di Circolo Hospital
city: Varese
country: Italy
facility: Macchi Hospital
city: Venezia
country: Italy
facility: SS. Giovanni e Paolo Hospital
Study officials:
affiliation: San Filippo Neri Hospital, Rome, Italy
name: Renato Pietro Ricci
role: PRINCIPAL_INVESTIGATOR
affiliation: San Filippo Neri Hospital, Rome, Italy
name: Loredana Morichelli
role: STUDY_CHAIR
affiliation: Policlinico universitario, University of Padua, Italy
name: Gianfranco Buja
role: STUDY_CHAIR
affiliation: Policlinico Casilino, Rome, Italy
name: Leonardo Calò
role: STUDY_CHAIR
affiliation: Spedali Civili, University of Brescia, Italy
name: Antonio Curnis
role: STUDY_CHAIR
affiliation: Monaldi Hospital, Italy
name: Antonio D'Onofrio
role: STUDY_CHAIR
affiliation: Montebelluna Hospital, Italy
name: Diego Vaccari
role: STUDY_CHAIR
affiliation: Legnago Hospital, Verona, Italy
name: Gabriele Zanotto
role: STUDY_CHAIR
affiliation: Biotronik Italia
name: Alessio Gargaro
role: STUDY_CHAIR
affiliation: Biotronik Italia
name: Nicola Rovai
role: STUDY_CHAIR
References:
citation: 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.