Status:
COMPLETED
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Ventricular Fibrillation
Ventricular Tachycardia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces d...
Detailed Description
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces d...
Eligibility Criteria
Inclusion
- Indication for implantation of an implantable cardioverter-defibrillator (ICD) according to the patient selection criteria used in the MADIT-II trial:
- Myocardial infarction 1 month or more prior to entry
- Ejection fraction of 30% or less within 3 months before entry
Exclusion
- NYHA functional class IV
- Coronary revascularization later than 5 days after ICD implantation
- First myocardial infarction within the past month
- Advanced cerebrovascular disease
- Any condition with a likelihood of death within the next 12 months
- Pacing indication
- Conventional ICD indication (i.e., criteria other than MADIT II)
- Living in an area with insufficient GSM coverage
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00401466
Start Date
January 1 2004
End Date
July 1 2008
Last Update
January 17 2011
Active Locations (5)
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1
Institute of clinical and experimental medicine
Prague, Czechia, 14021
2
Hospital Na Homolce
Prague, Czechia, 15030
3
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
4
Herz- und Gefäßklinikum Bad Neustadt GmbH
Bad Neustadt an der Saale, Germany, 97616