Status:
COMPLETED
Survival of Patients With Primary Prophylactic ICD Indication
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Primary Prevention
Tachycardia, Ventricular
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). How...
Detailed Description
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). How...
Eligibility Criteria
Inclusion
- Indication for ICD implantation according to MADIT-II:
- Myocardial infarction 30 days or more before implantation
- LVEF of 30% or less within 3 months before implantation
- Angiography within the preceding 12 months
- The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent
Exclusion
- Patients with contraindication for ICD implantation
- Conventional ICD indication (i.e. other than MADIT-II)
- Myocardial infarction within the past 30 days
- Coronary revascularisation within the preceding 3 months (i.e., if revascularization has been performed wait at least 3 months until enrolment, given that no appropriate/ inappropriate ICD therapy has occured)
- NYHA functional class IV
- Unexplained syncope within 3 years
- Advanced cerebrovascular disease
- Life expectancy very probably below 12 months
- Pregnant or breast-feeding women
- Age \< 18 years
- Patients who are already enrolled in another study (therapy/intervention phase)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00619593
Start Date
February 1 2008
End Date
July 1 2014
Last Update
January 12 2015
Active Locations (37)
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1
A.ö. Krankenhaus der Stadt Linz
Linz, Austria, 4020
2
Landesklinikum St. Pölten
Sankt Pölten, Austria, 3100
3
Wilhelminenspital der Stadt Wien
Vienna, Austria, 1160
4
Brno Bohunice
Brno, Czechia, 62500