RecruitingNot ApplicableNCT04440254

Long Duration Holter ECG in Fabry Disease

Natural History of Cardiac Rhythm and Conduction Disorders in Patients With Fabry Disease Evaluated by Long-Term Implantable Holter ECG


Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

40 participants

Start Date

May 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective is to assess the occurrence of cardiac arrhythmias and conduction disorders during a three-year follow-up using implantable Holter ECG monitoring in 40 patients with Fabry disease. The secondary objectives are to analyze the correlations of these anomalies with changes in cardiac MRI and echocardiographic parameters as biological parameters and overall severity of the disease assessed by MSSI.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring the heart rhythm of men with Fabry disease (a rare inherited condition) over a long period using a wearable ECG (Holter) device, to detect any silent or dangerous heart rhythm problems. **You may be eligible if...** - You are male - You are 18 or older - You have a confirmed genetic mutation for Fabry disease - You do not have significant heart valve disease **You may NOT be eligible if...** - You are female (this study is for male participants only) - You have a pacemaker or implanted heart device that would interfere with monitoring - You have significant valve disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTImplantation (subcutaneous) of a marketed miniaturized Holter ECG recording device

Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region


Locations(1)

20 Rue Leblanc, HEGP/PARCC, 75015 Paris

Paris, Paris, France

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NCT04440254


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