Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients

Sponsor

San Filippo Neri General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01459874

Collaborator

Biotronik Italia (Industry)

1,650

Enrollment

Locations

Duration (Months)

22.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker Implantable Cardioverter Defibrillator	Behavioral: Organizational model for remote monitoring

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:

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

Study Design

Study Type:

Observational

Actual Enrollment :

1650 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Cardiac Implantable Device recipients	Behavioral: 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 Names: Biotronik Home Monitoring

Arm

Intervention/Treatment

Cardiac Implantable Device recipients

Behavioral: 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 Names:

Biotronik Home Monitoring

Outcome Measures

Primary Outcome Measures

Sensitivity, positive predictive value and expected utility of the organizational model [Up to two years]
Sensitivity, positive predictive value and expected utility in the detection of all cardiovascular and device-related events of the proposed organizational model

Secondary Outcome Measures

Manpower of the organizational model [Up to two years]
Health care source consumption required to implement the organizational model for the remote management of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Senigallia Civil Hospital	Senigallia	Ancona	Italy
2	Presidio Ospedale di Ariano Irpino	Ariano Irpino	Avellino	Italy
3	Umberto I Hospital	Altamura	Bari	Italy
4	Michele Sarcone Hospital	Terlizzi	Bari	Italy
5	PO Francesco Ferrari	Casarano	Lecce	Italy
6	P.O.G. Fogliani	Milazzo	Messina	Italy
7	Ospedale di Circolo	Desio	Monza e Brianza	Italy
8	San Leonardo	Castellammare di Stabia	Napoli	Italy
9	Volterra Hospital	Volterra	Pisa	Italy
10	SS. Cosimo e Damiano Hospital	Pescia	Pistoia	Italy
11	P. O. Villa D'Agri	Marsicovetere	Potenza	Italy
12	Guizzardi Hospital	Vittoria	Ragusa	Italy
13	G. B. Grassi	Ostia	Roma	Italy
14	Santa Maria Della Misericordia Hospital	Sorrento	Salerno	Italy
15	P.O. Giannuzzi	Manduria	Taranto	Italy
16	Paolo Borsellino Hospital	Marsala	Trapani	Italy
17	Ulss n. 7	Conegliano	Treviso	Italy
18	Montebelluna Hospital	Montebelluna	Treviso	Italy
19	ULSS n. 14	Chioggia	Venezia	Italy
20	Dell'Angelo Hospital	Mestre	Venezia	Italy
21	Mirano Hospital	Mirano	Venezia	Italy
22	Portogruaro Hospital	Portogruaro	Venezia	Italy
23	Mater Salutis Hospital	Legnago	Verona	Italy
24	G.M. Lancisi Hospital	Ancona		Italy
25	I.N.R.C.A.	Ancona		Italy
26	S. Donato di Arezzo Hospital	Arezzo		Italy
27	Policlinico - Card. Universitaria	Bari		Italy
28	Policlinico - Cardiologia Ospedaliera	Bari		Italy
29	Policlinico - Cardiologia Ospedaliera	Benevento		Italy
30	AO Spedali Civili	Brescia		Italy
31	Congreg. Ancelle della Carità Poliambulanza	Brescia		Italy
32	A. Perrino Hospital	Brindisi		Italy
33	Cardarelli Hospital	Campobasso		Italy
34	S. Cuore University	Campobasso		Italy
35	Carrara Civil Hospital	Carrara		Italy
36	Sant'Anna e San Sebastiani Hospital	Caserta		Italy
37	Ferrarotto Hospital	Catania		Italy
38	AO Arcispedale S. Anna	Ferrara		Italy
39	A.O.U. Careggi S.O.D. Aritmologia	Firenze		Italy
40	S. Giovanni di Dio Hospital	Firenze		Italy
41	S. Maria Annunziata Hospital	Firenze		Italy
42	S. Maria Nuova Hospital	Firenze		Italy
43	P.O. Di Gorizia	Gorizia		Italy
44	F. Veneziale Hospital	Isernia		Italy
45	Vito Fazzi Hospital	Lecce		Italy
46	Piemonte Hospital	Messina		Italy
47	Sacco Hospital	Milano		Italy
48	F.B.F.	Napoli		Italy
49	Federico II Hospital	Napoli		Italy
50	Monaldi Hospital - Gruppo Sun	Napoli		Italy
51	Monaldi Hospital, U.O. Aritmologia	Napoli		Italy
52	Policlinico Federico II	Napoli		Italy
53	Policlinico Universitario di Padova	Padova		Italy
54	ARNAS Civico	Palermo		Italy
55	Cervello Hospital	Palermo		Italy
56	Santa Maria della Misericordia Hospital	Perugia		Italy
57	Guglielmo da Saliceto Civil Hospital	Piacenza		Italy
58	Santa Maria degli Angeli Hospital	Pordenone		Italy
59	Santa Maria Nuova Hospital	Reggio Emilia		Italy
60	Degli Infermi Hospital	Rimini		Italy
61	Casa di Cura Villa Pia	Roma		Italy
62	Policlinico Casilino	Roma		Italy
63	Policlinico Tor Vergata	Roma		Italy
64	Policlinico Umberto I	Roma		Italy
65	San Filippo Neri Hospital	Rome		Italy
66	San Giovanni di Dio e Ruggi D'Aragona Hospital	Salerno		Italy
67	San Donà di Piave Hospital	San Donà di Piave		Italy
68	Teresa Masselli Mascia Hospital	San Severo		Italy
69	P.O. SS. Annunziata	Taranto		Italy
70	Sant'Antonio Abate Hospital	Trapani		Italy
71	Ca' Foncello Hospital	Treviso		Italy
72	Di Circolo Hospital	Varese		Italy
73	Macchi Hospital	Varese		Italy
74	SS. Giovanni e Paolo Hospital	Venezia		Italy

Sponsors and Collaborators

San Filippo Neri General Hospital
Biotronik Italia

Investigators

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