Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre de référence pour les cardiomyopathies et les troubles du rythme héréditaires ou rares - UF de Génétique, Hôpital Ambroise Paré,
RECRUITING
Boulogne-billancourt
Contact Information
Primary
Philippe CHARRON, MD, PhD
philippe.charron@aphp.fr
+ 33 1 49 09 55 43
Time Frame
Start Date: 2020-09-23
Estimated Completion Date: 2027-03
Participants
Target number of participants: 2000
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov