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โ† Trials
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Subcutaneous Implantable Cardioverter-defibrillator (S-ICD) Eligibility Over Time in Arrhythmogenic Cardiomyopathy

Recruitingn/aAges 18 Years - anyAllUniversity of Sao Paulo
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn whether adults with arrhythmogenic cardiomyopathy, an inherited heart muscle disease that can cause dangerous heart rhythms, remain eligible for a subcutaneous implantable cardioverter-defibrillator (S-ICD) over time. An S-ICD is a device placed under the skin, outside the heart, that can stop life-threatening heart rhythms with an electric shock. Before an S-ICD is implanted, a screening test checks whether the heart's electrical signals, recorded from the skin of the chest, are suitable for the device to work correctly. Because arrhythmogenic cardiomyopathy is a progressive disease, these signals may change over time, and a patient who passes the screening today may not pass it later. The main questions it aims to answer are: * Does S-ICD eligibility remain stable over 18 months in patients with arrhythmogenic cardiomyopathy? * Are ch

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Arrhythmogenic cardiomyopathy group Inclusion Criteria: * Age 18 years or older * Diagnosis of arrhythmogenic right ventricular cardiomyopathy according to the updated 2010 Task Force criteria, or arrhythmogenic left ventricular cardiomyopathy according to the Padua criteria * Risk stratification for primary prevention of sudden cardiac death using the ARVC risk calculator (\<5% = low risk; 5% to 10% = intermediate risk; \>10% = high risk) or the 2015 International Task Force consensus; or secondary prevention (documented ventricular tachycardia or resuscitated cardiac arrest) Exclusion Criteria: * Ventricular pacing by an artificial pacemaker * Heart transplantation * Refusal to sign the informed consent form * Comorbidities with a life expectancy of less than 1 year (e.g., advanced malignancy) Brugada syndrome reference group Inclusion Criteria: * Age 18 years or older * Type 1 Brugada ECG pattern, spontaneous or drug-induced Exclusion Criteria: * Ventricular pacing by an artificial pacemaker * Heart transplantation * Refusal to sign the informed consent form * Comorbidities with a life expectancy of less than 1 year (e.g., advanced malignancy) Control group Inclusion Criteria: * Age 18 years or older * No structural heart disease, defined by a transthoracic echocardiogram with all parameters within normal reference values Exclusion Criteria: * Structural heart disease on transthoracic echocardiography * Ventricular pacing by an artificial pacemaker * Heart transplantation * Refusal to sign the informed consent form * Comorbidities with a life expectancy of less than 1 year (e.g., advanced malignancy)
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What it tests

  • Subcutaneous ICD ECG screening
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Where

1 site
Heart Institute
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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