RECRUITINGOBSERVATIONAL
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- Specific etiologies such as amyloidosis
- Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Locations (1)
Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,
Boulogne-Billancourt, Hauts-de-Seine, France