PREVENTION-ACHD Risk Score (PREVENTIONACHD)
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|ClinicalTrials.gov Identifier: NCT03957824|
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
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.
|Condition or disease||Intervention/treatment|
|Death, Sudden, Cardiac Ventricular Fibrillation Ventricular Tachycardia Congenital Heart Disease||Diagnostic Test: PREVENTION-ACHD risk score|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||783 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects|
|Actual Study Start Date :||January 1, 2015|
|Actual Primary Completion Date :||December 31, 2015|
|Actual Study Completion Date :||June 30, 2018|
- 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
- Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia [ Time Frame: 2 years ]The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients
- Sudden cardiac death [ Time Frame: 2 years ]The rate of sudden cardiac death in adult congenital heart disease patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957824
|Principal Investigator:||Joris R de Groot, MD, PhD||Academic Medical Center - University of Amsterdam (AMC-UvA)|