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OpenTrials
Completed

NCT Number: NCT01459874

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Senigallia Civil Hospital, Senigallia, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Organizational model for remote monitoring

Behavioral

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

Other names: Biotronik Home Monitoring

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

San Filippo Neri General Hospital

Other

Collaborators

  • Biotronik Italia

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 26, 2011
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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