Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorAssistance Publique - Hôpitaux de Paris

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Specific etiologies such as amyloidosis

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed