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

San Filippo Neri General Hospital

Status: Completed

Conditions: Pacemaker; Implantable Cardioverter Defibrillator

Treatments: Behavioral: Organizational model for remote monitoring

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01459874

HomeGuide

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,650 patients

Sex: All

Volunteers: No 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

Trial design

1,650 participants in 1 patient group

Cardiac Implantable Device recipients

Treatment:

Behavioral: Organizational model for remote monitoring