PREVENTION-ACHD Risk Score (PREVENTIONACHD)

May 19, 2019 updated by: Joris R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Study Type

Observational

Enrollment (Actual)

783

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with congenital heart disease with a diagnosis of one of the congenital heart defects displayed in the risk score model.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joris R de Groot, MD, PhD, Academic Medical Center - University of Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 31, 2015

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

May 19, 2019

First Submitted That Met QC Criteria

May 19, 2019

First Posted (ACTUAL)

May 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 19, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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