Congenital Heart Disease Clinical Trial
Official title:
PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects
Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital
heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is
challenging and at the current moment there are no clear guidelines on implantable
cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young
patient population. The reason for this is the fact that this is a heterogenous group of
patients and SCD is a relatively rare event. Because of this there have been no prospective
studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD
have shown that this treatment does appear to be effective. Researchers from the Academic
Medical Center have identified several risk factors for sudden cardiac death. A risk score
was created using this data, which has been validated in an internal and external cohort in a
retrospective setting. The design of this study, including the conception of the risk score,
its calculation method and validation will be published in an international scientific
peer-reviewed journal.
The hypothesis of this study is that the risk score accurately predicts the risk of sudden
cardiac death.
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