Skip to content

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

Prospective Registry for the Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator (ICD) Recipients in the Clinical Practice

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01459874
Enrollment
1650
Registered
2011-10-26
Start date
2008-03-31
Completion date
2011-12-31
Last updated
2013-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantable Cardioverter Defibrillator, Pacemaker

Keywords

Home Monitoring, Remote monitoring, Telecardiology, Organizational model, Patient indicated for pacemaker, ICD, CRT-P, or CRT-D

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.

Interventions

BEHAVIORALOrganizational model for remote monitoring

An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients

Sponsors

Biotronik Italia
CollaboratorINDUSTRY
San Filippo Neri General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity, positive predictive value and expected utility of the organizational modelUp to two yearsSensitivity, positive predictive value and expected utility in the detection of all cardiovascular and device-related events of the proposed organizational model

Secondary

MeasureTime frameDescription
Manpower of the organizational modelUp to two yearsHealth care source consumption required to implement the organizational model for the remote management of patients

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026