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RECRUITING
NCT04440254
NA

Long Duration Holter ECG in Fabry Disease

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-05-05

Completion Date

2029-04-30

Last Updated

2026-02-18

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Implantation (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