Status:
UNKNOWN
Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
Lead Sponsor:
F. Mueller-Riemenschneider
Collaborating Sponsors:
Biotronik SE & Co. KG
Conditions:
Ventricular Arrythmias
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.
Detailed Description
Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complic...
Eligibility Criteria
Inclusion
- The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires
- Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines
Exclusion
- Age \< 18 and \> 80 years
- Expected non-compliance
- Known drug or alcohol abuse
- Life expectancy \< 1 year
- NYHA classification IV
- Participation in another clinical study
- Participation in another telemonitoring concept
- Pregnant or breast-feeding woman
- Uncontrolled hypertension
- No mobile phone use possible in patient residence
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00787683
Start Date
October 1 2008
End Date
December 1 2012
Last Update
June 26 2012
Active Locations (13)
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1
Asklepios Hospital Barmbeck in Hamburg
Hamburg, Hamburg, Germany, 22291
2
Hospital Bremerhaven
Bremerhaven, Lower Saxony, Germany, 27574
3
MH-Hannover
Hanover, Lower Saxony, Germany, 30625
4
University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany, 52074