Actively Recruiting

Age: 16Years +
All Genders
NCT03846297

Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-03-16

2000

Participants Needed

1

Research Sites

335 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with hypertrophic cardiomyopathy (HCM) based on standard criteria (left ventricle wall thickness  15 mm in adults or  13 mm in adult relatives) without abnormal loading conditions
  • Aged 16 years or older
  • Patient without a defibrillator or with a defibrillator implanted for primary prevention
  • Affiliated to a social security insurance
Not Eligible

You will not qualify if you...

  • Specific causes such as amyloidosis
  • Patients with defibrillators implanted for secondary prevention after aborted sudden cardiac death or sustained ventricular arrhythmia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

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

Actively Recruiting

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Research Team

P

Philippe CHARRON, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy | DecenTrialz