Status:
COMPLETED
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Arrhythmia
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A close therapeuti...
Detailed Description
Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and freque...
Eligibility Criteria
Inclusion
- Indication for ICD implantation either as primary or secondary prevention
- Patient informed consent
Exclusion
- ICD replacement indication
- Indication for cardiac resynchronisation therapy
- Inability to fully understand psychosomatic questionnaires, especially cognitive impairment or German language deficits
- Co-morbidities with a resulting life expectancy of less than one year
- Psychosomatic disease (requiring psychiatric therapy)
- Age \<18 years
- Patients who are already enrolled in another study
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00325221
Start Date
August 1 2006
End Date
October 1 2012
Last Update
January 31 2013
Active Locations (7)
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1
Krankenhaus der Barmherzigen Schwestern Ried
Ried, Austria, 4910
2
Hanusch-Krankenhaus
Vienna, Austria, 1140
3
Herzzentrum Coswig
Coswig, Germany, 06869
4
Universitätsklinikum Erlangen
Erlangen, Germany, 91054