Status:
COMPLETED
Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients
Lead Sponsor:
San Filippo Neri General Hospital
Collaborating Sponsors:
Biotronik Italia
Conditions:
Pacemaker
Implantable Cardioverter Defibrillator
Eligibility:
All Genders
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. T...
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 implemen...
Eligibility Criteria
Inclusion
- 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
- Patients who do not fulfill all inclusion criteria
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1650 Patients enrolled
Trial Details
Trial ID
NCT01459874
Start Date
March 1 2008
End Date
December 1 2011
Last Update
March 28 2013
Active Locations (74)
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1
Senigallia Civil Hospital
Senigallia, Ancona, Italy
2
Presidio Ospedale di Ariano Irpino
Ariano Irpino, Avellino, Italy
3
Umberto I Hospital
Altamura, Bari, Italy
4
Michele Sarcone Hospital
Terlizzi, Bari, Italy