CompletedPhase 4

Survival of Patients With Primary Prophylactic ICD Indication

Austria, Czechia504 participantsStarted 2008-02

Plain-language 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). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients. This trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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)

What they're measuring

Mortality

Timeframe: 12 months

Trial details

NCT IDNCT00619593

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04