Status:
COMPLETED
Home Monitoring in Cardiac Resynchronisation Therapy
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Brief Summary
In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated...
Detailed Description
Clinical investigations identified potential predictors for mortality and rehospitalisation events in heart failure patients. A selection of these predictors primarily composes the "Heart Failure Moni...
Eligibility Criteria
Inclusion
- Written patient informed consent
- Indication for CRT (biventricular or bifocal)
- Sufficient GSM-network coverage in the patient's area
- Stable residence during follow-up (anticipated)
- at least 1 documented hospitalisation due to heart failure within 12 months before enrolment
Exclusion
- Permanent atrial fibrillation
- Myocardial infarction or instable Angina Pectoris within the last 3 months
- Planned cardiac interventions within the next 3 months (e.g. PTCA, CABG, HTX)
- Acute myocarditis
- Life expectancy under 6 months
- Pregnant or breast-feeding woman
- Participation in another clinical study
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
513 Patients enrolled
Trial Details
Trial ID
NCT00376116
Start Date
March 1 2005
End Date
November 1 2008
Last Update
November 17 2008
Active Locations (82)
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1
LKH-Universitätsklinikum Graz
Graz, Austria, 8036
2
Medizinische Universität Wien
Vienna, Austria, 1080
3
Fakultni nemocnice u Svety Anny
Brno, Czechia, 65691
4
IKEM
Prague, Czechia, 14021