Informations générales (source: ClinicalTrials.gov)

NCT03846297 En recrutement IDF
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Observational
  • Cardiomyopathie hypertrophique
  • Hypertrophie
  • Cardiomyopathies
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2020
mars 2027
18 septembre 2025
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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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CENTRE CARDIOLOGIQUE DU NORD CHARRON Philippe En recrutement IDF 13/12/2025 07:41:35  Contacter
GH PARIS SITE SAINT JOSEPH CHARRON Philippe En recrutement IDF 13/12/2025 07:41:34  Contacter
HOPITAL PRIVE JACQUES CARTIER CHARRON Philippe En recrutement IDF 13/12/2025 07:41:35  Contacter
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 13/12/2025 07:41:37  Contacter
AP-HP - Hôpital Ambroise Paré
AP-HP - Hôpital Bicêtre
AP-HP - Hôpital Bichat
AP-HP - Hôpital Cochin
AP-HP - Hôpital Europeen Georges Pompidou
AP-HP - Hôpital Henri Mondor-Albert Chenevier
AP-HP - Hôpital La Pitié-Salpêtrière
AP-HP - Hôpital Lariboisiere-Fernand Widal
AP-HP - Hôpital Necker-Enfants Malades

Critères

Tous
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



- Specific etiologies such as amyloidosis

- Patients with ICD as secondary prevention (after aborted SCD or sustained
ventricular arrhythmia)