Status:
RECRUITING
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
16+ years
Brief 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 deat...
Detailed Description
HCM is a genetic disease, usually autosomal dominant, with a prevalence of about 1/500 in the general population. HCM represents a major cause of SCD in the young, and is the first cause of SCD in ath...
Eligibility Criteria
Inclusion
- 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
- Specific etiologies such as amyloidosis
- Patients with ICD as secondary prevention (after aborted SCD or sustained ventricular arrhythmia)
Key Trial Info
Start Date :
September 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03846297
Start Date
September 23 2020
End Date
March 1 2027
Last Update
March 16 2023
Active Locations (1)
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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, 92100