Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Assistance Publique - Hôpitaux de Paris
2,000 participants
Sep 23, 2020
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria4
- 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 Criteria2
- Specific etiologies such as amyloidosis
- Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03846297