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Trial record 83 of 132 for:    "Paroxysmal Ventricular Fibrillation"

PREVENTION-ACHD Risk Score (PREVENTIONACHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03957824
Recruitment Status : Completed
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Joris R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.


Condition or disease Intervention/treatment
Death, Sudden, Cardiac Ventricular Fibrillation Ventricular Tachycardia Congenital Heart Disease Diagnostic Test: PREVENTION-ACHD risk score

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Study Type : Observational [Patient Registry]
Actual Enrollment : 783 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sudden cardiac death [ Time Frame: 2 years ]
    The rate of sudden cardiac death in adult congenital heart disease patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Joris R de Groot, MD, PhD Academic Medical Center - University of Amsterdam (AMC-UvA)

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Responsible Party: Joris R. de Groot, Professor of Cardiac Electrophysiology and Atrial Fibrillation, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03957824     History of Changes
Other Study ID Numbers: 2014_248#C20141535
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joris R. de Groot, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Risk score
Risk prediction
Prevention

Additional relevant MeSH terms:
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Ventricular Fibrillation
Heart Diseases
Death
Tachycardia
Tachycardia, Ventricular
Death, Sudden
Death, Sudden, Cardiac
Cardiovascular Diseases
Pathologic Processes
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Heart Arrest