NCT03957824

PREVENTION-ACHD Risk Score

PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 783 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Death, Sudden, Cardiac
• Ventricular Fibrillation
• Ventricular Tachycardia
• Congenital Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PREVENTION-ACHD risk score	The predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-31
• Completion: 2018-06-30
• First posted: 2019-05-21
• Last updated: 2019-05-21