Status:
COMPLETED
Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Implantable Cardioverter-Defibrillators
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to...
Detailed Description
State-of-the-art implantable cardioverter defibrillators (ICD) provide a variety of algorithms to optimize episode classification and to minimize the danger of delivering inadequate therapies. An impo...
Eligibility Criteria
Inclusion
- Indication for single or dual chamber ICD
Exclusion
- NYHA class IV
- Pregnant woman or woman who plan to become pregnant during the trial
- Patient whose medical situation is not stable
- Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl), liver failure, etc.
- Age \< 18 years
- Patient unable to handle Home Monitoring system correctly
- The patient is not willing and able to comply with the protocol
- Change of residence expected during study
- Insufficient GSM coverage at patient's home
- Participation in another clinical study
- Patient unwilling to sign the consent for participation.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00989417
Start Date
January 1 2007
End Date
October 1 2010
Last Update
May 25 2011
Active Locations (1)
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1
CHRU de Lille- Hôpital Cardiologique
Lille, France