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

This study has been completed.
Sponsor:
Collaborator:
Biotronik Italia
Information provided by (Responsible Party):
Renato Pietro Ricci, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT01459874
First received: October 24, 2011
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pacemaker
Implantable Cardioverter Defibrillator
Behavioral: Organizational model for remote monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:
  • Sensitivity, positive predictive value and expected utility of the organizational model [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    Sensitivity, positive predictive value and expected utility in the detection of all cardiovascular and device-related events of the proposed organizational model


Secondary Outcome Measures:
  • Manpower of the organizational model [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    Health care source consumption required to implement the organizational model for the remote management of patients


Enrollment: 1650
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiac Implantable Device recipients Behavioral: Organizational model for remote monitoring
An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients
Other Name: Biotronik Home Monitoring

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiac Implantable Device recipients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459874

  Show 74 Study Locations
Sponsors and Collaborators
San Filippo Neri General Hospital
Biotronik Italia
Investigators
Principal Investigator: Renato Pietro Ricci San Filippo Neri Hospital, Rome, Italy
Study Chair: Loredana Morichelli San Filippo Neri Hospital, Rome, Italy
Study Chair: Gianfranco Buja Policlinico universitario, University of Padua, Italy
Study Chair: Leonardo Calò Policlinico Casilino, Rome, Italy
Study Chair: Antonio Curnis Spedali Civili, University of Brescia, Italy
Study Chair: Antonio D'Onofrio Monaldi Hospital, Italy
Study Chair: Diego Vaccari Montebelluna Hospital, Italy
Study Chair: Gabriele Zanotto Legnago Hospital, Verona, Italy
Study Chair: Alessio Gargaro Biotronik Italia
Study Chair: Nicola Rovai Biotronik Italia
  More Information

Publications:
Responsible Party: Renato Pietro Ricci, Principal Investigator, San Filippo Neri General Hospital
ClinicalTrials.gov Identifier: NCT01459874     History of Changes
Other Study ID Numbers: HomeGuide
Study First Received: October 24, 2011
Last Updated: March 26, 2013
Health Authority: Italy: Ethics Committee
Italy: National Institute of Health

Keywords provided by San Filippo Neri General Hospital:
Home Monitoring
Remote monitoring
Telecardiology
Organizational model
Patient indicated for pacemaker, ICD, CRT-P, or CRT-D

ClinicalTrials.gov processed this record on September 18, 2014