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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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