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Trial record 2 of 6 for:    biotronik home monitor

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01459874
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : March 28, 2013
Information provided by (Responsible Party):

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
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:

  1. Clinical efficiency of remote patient management;
  2. 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 : March 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort 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 Name: Biotronik Home Monitoring

Outcome Measures

Primary Outcome Measures :
  1. Sensitivity, positive predictive value and expected utility of the organizational model [ Time Frame: 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 :
  1. Manpower of the organizational model [ Time Frame: Up to two years ]
    Health care source consumption required to implement the organizational model for the remote management of patients

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac Implantable Device recipients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459874

  Hide Study Locations
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, 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
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
Firenze, Italy
S. Giovanni di Dio Hospital
Firenze, Italy
S. Maria Annunziata Hospital
Firenze, Italy
S. Maria Nuova Hospital
Firenze, Italy
P.O. Di Gorizia
Gorizia, Italy
F. Veneziale Hospital
Isernia, Italy
Vito Fazzi Hospital
Lecce, Italy
Piemonte Hospital
Messina, Italy
Sacco Hospital
Milano, Italy
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
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
Sponsors and Collaborators
San Filippo Neri General Hospital
Biotronik Italia
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
More Information

Responsible Party: Renato Pietro Ricci, Principal Investigator, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier: NCT01459874     History of Changes
Other Study ID Numbers: HomeGuide
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Keywords provided by Renato Pietro Ricci, San Filippo Neri General Hospital:
Home Monitoring
Remote monitoring
Organizational model
Patient indicated for pacemaker, ICD, CRT-P, or CRT-D