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Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

Recruitingn/aAges 16 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT03846297 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The main objective of the study is to improve implantable cardioverter defibrillator (ICD) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM), including newly identified potential biomarkers by magnetic resonance imaging (MRI) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk. The secondary objective is to perform a medico-economic analysis of ICD implantation in order to define an optimal rule for ICD implantation in patients with HCM, taking into account the benefits of ICD, adverse effects of ICD and associated costs (cost of quality adjusted life years saved).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient with a diagnosis of HCM based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions * Aged ≥ 16 years * Patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention) * Affiliation to a social security insurance Exclusion Criteria: * Specific etiologies such as amyloidosis * Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
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What it tests

  • Not listed
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Where

1 site
Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,
Boulogne-Billancourt, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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