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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pacemaker, Implantable Cardioverter Defibrillator

Intervention / Treatment
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* Behavioral: Organizational model for remote monitoring


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Implantable Device recipients<br> | Behavioral: Organizational model for remote monitoring<br>* An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients<br>* Other names: Biotronik Home Monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manpower of the organizational model | Health care source consumption required to implement the organizational model for the remote management of patients | Up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Monitoring, Remote monitoring, Telecardiology, Organizational model, Patient indicated for pacemaker, ICD, CRT-P, or CRT-D