PacemakerNCT01459874
Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients
An observational study of Pacemaker and Implantable Cardioverter Defibrillator, run by San Filippo Neri General Hospital at 74 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker, Implantable Cardioverter Defibrillator
- What is being tested?
- Organizational model for remote monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,650 participants
- Where
- 74 sitesItaly
- Study dates
- Mar 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardiac Implantable Device recipients
Who may be able to join
- 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
Who cannot join
- Patients who do not fulfill all inclusion criteria
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
Italy74 sites
Umberto I Hospital
Altamura, Bari
G.M. Lancisi Hospital
Ancona
I.N.R.C.A.
Ancona
S. Donato di Arezzo Hospital
Arezzo
Presidio Ospedale di Ariano Irpino
Ariano Irpino, Avellino
Policlinico - Card. Universitaria
Bari
Policlinico - Cardiologia Ospedaliera
Bari
Policlinico - Cardiologia Ospedaliera
Benevento
AO Spedali Civili
Brescia
Congreg. Ancelle della Carità Poliambulanza
Brescia
A. Perrino Hospital
Brindisi
Cardarelli Hospital
Campobasso
S. Cuore University
Campobasso
Carrara Civil Hospital
Carrara
PO Francesco Ferrari
Casarano, Lecce
Sant'Anna e San Sebastiani Hospital
Caserta
San Leonardo
Castellammare di Stabia, Napoli
Ferrarotto Hospital
Catania
ULSS n. 14
Chioggia, Venezia
Ulss n. 7
Conegliano, Treviso
Ospedale di Circolo
Desio, Monza E Brianza
AO Arcispedale S. Anna
Ferrara
A.O.U. Careggi S.O.D. Aritmologia
Florence
S. Giovanni di Dio Hospital
Florence
S. Maria Annunziata Hospital
Florence
S. Maria Nuova Hospital
Florence
P.O. Di Gorizia
Gorizia
F. Veneziale Hospital
Isernia
Vito Fazzi Hospital
Lecce
Mater Salutis Hospital
Legnago, Verona
P.O. Giannuzzi
Manduria, Taranto
Paolo Borsellino Hospital
Marsala, Trapani
P. O. Villa D'Agri
Marsicovetere, Potenza
Piemonte Hospital
Messina
Dell'Angelo Hospital
Mestre, Venezia
Sacco Hospital
Milan
P.O.G. Fogliani
Milazzo, Messina
Mirano Hospital
Mirano, Venezia
Montebelluna Hospital
Montebelluna, Treviso
F.B.F.
Naples
Federico II Hospital
Naples
Monaldi Hospital - Gruppo Sun
Naples
Monaldi Hospital, U.O. Aritmologia
Naples
Policlinico Federico II
Naples
G. B. Grassi
Ostia Antica, Roma
Policlinico Universitario di Padova
Padova
ARNAS Civico
Palermo
Cervello Hospital
Palermo
Santa Maria della Misericordia Hospital
Perugia
SS. Cosimo e Damiano Hospital
Pescia, Pistoia
Guglielmo da Saliceto Civil Hospital
Piacenza
Santa Maria degli Angeli Hospital
Pordenone
Portogruaro Hospital
Portogruaro, Venezia
Santa Maria Nuova Hospital
Reggio Emilia
Degli Infermi Hospital
Rimini
Casa di Cura Villa Pia
Roma
Policlinico Casilino
Roma
Policlinico Tor Vergata
Roma
Policlinico Umberto I
Roma
San Filippo Neri Hospital
Rome
San Giovanni di Dio e Ruggi D'Aragona Hospital
Salerno
San Donà di Piave Hospital
San Donà di Piave
Teresa Masselli Mascia Hospital
San Severo
Senigallia Civil Hospital
Senigallia, Ancona
Santa Maria Della Misericordia Hospital
Sorrento, Salerno
P.O. SS. Annunziata
Taranto
Michele Sarcone Hospital
Terlizzi, Bari
Sant'Antonio Abate Hospital
Trapani
Ca' Foncello Hospital
Treviso
Di Circolo Hospital
Varese
Macchi Hospital
Varese
SS. Giovanni e Paolo Hospital
Venezia
Guizzardi Hospital
Vittoria, Ragusa
Volterra Hospital
Volterra, Pisa
About this study
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
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.
Read the 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.
- Conditions
- Pacemaker, Implantable Cardioverter Defibrillator
- Being tested
- Organizational model for remote monitoring
- Keywords
- Home Monitoring, Remote monitoring, Telecardiology, Organizational model, Patient indicated for pacemaker, ICD, CRT-P, or CRT-D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organizational model for remote monitoringBehavioural
Also called Biotronik Home Monitoring
An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Implantable Device recipients | Not described Receives: Behavioral: Organizational model for remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to two years
Secondary outcomes (1)
Manpower of the organizational model
Health care source consumption required to implement the organizational model for the remote management of patients
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startMar 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik Italia
- Responsible party
- Principal investigator, Renato Pietro Ricci, San Filippo Neri General Hospital
- Investigators
- Renato Pietro Ricci, Principal investigator, San Filippo Neri Hospital, Rome, ItalyLoredana Morichelli, Study chair, San Filippo Neri Hospital, Rome, ItalyGianfranco Buja, Study chair, Policlinico universitario, University of Padua, ItalyLeonardo Calò, Study chair, Policlinico Casilino, Rome, ItalyAntonio Curnis, Study chair, Spedali Civili, University of Brescia, ItalyAntonio D'Onofrio, Study chair, Monaldi Hospital, ItalyDiego Vaccari, Study chair, Montebelluna Hospital, ItalyGabriele Zanotto, Study chair, Legnago Hospital, Verona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459874
- Sponsor's protocol ID
- HomeGuide
- Status last verified
- Mar 2013
- First submitted
- 24 Oct 2011
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23362021
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01459874
- Acronym / sponsor ID
- HomeGuide
- Conditions
- Pacemaker, Implantable Cardioverter Defibrillator
- Keywords
- Home Monitoring, Remote monitoring, Telecardiology, Organizational model, Patient indicated for pacemaker, ICD, CRT-P, or CRT-D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Collaborators
- Biotronik Italia
- Study start
- Mar 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Clinical efficiency of remote patient management;
- Health service resources required by a remote patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Implantable Device recipients | – | Behavioral: Organizational model for remote monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiac Implantable Device recipients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not fulfill all inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organizational model for remote monitoringAlso: Biotronik Home MonitoringAn organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients | Behavioural | Cardiac Implantable Device recipients |
Primary outcome
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
1 secondary outcome
Manpower of the organizational model
Time frame: Up to two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
- Results publication: PubMed 23362021Ricci 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato Pietro Ricci principal investigator
San Filippo Neri Hospital, Rome, Italy
Loredana Morichelli study chair
San Filippo Neri Hospital, Rome, Italy
Gianfranco Buja study chair
Policlinico universitario, University of Padua, Italy
74 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and Implantable Cardioverter Defibrillator, run by San Filippo Neri General Hospital at 74 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, positive predictive value and expected utility of the organizational model (time frame: Up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.