- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957824
PREVENTION-ACHD Risk Score (PREVENTIONACHD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult (≥18 years old) patient with a diagnosis of a congenital heart defect.
Exclusion Criteria:
Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.
- Patients with documented sustained ventricular tachycardia or ventricular fibrillation.
- Patients for whom the risk is not calculable because of a congenital heart disease diagnose not represented in the risk score.
- Patients for whom the risk score is not calculable because of missing data
- Patients with recent (<3 months ago) myocardial infarction.
- Patients in whom the high SCD-risk status depends on an impaired ejection fraction that is expected to improve, e.g. due to tachycardiomyopathy.
- Patients with a guideline defined contraindication for ICD implantation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sudden cardiac death
Time Frame: 2 years
|
The rate of sudden cardiac death in adult congenital heart disease patients
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joris R de Groot, MD, PhD, Academic Medical Center - University of Amsterdam (AMC-UvA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Congenital Abnormalities
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Cardiovascular Abnormalities
- Heart Arrest
- Heart Diseases
- Death
- Ventricular Fibrillation
- Tachycardia
- Tachycardia, Ventricular
- Heart Defects, Congenital
- Death, Sudden, Cardiac
- Death, Sudden
Other Study ID Numbers
- 2014_248#C20141535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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