S-ICD Eligibility Over Time in Arrhythmogenic Cardiomyopathy
Official title: Evaluation of Subcutaneous Implantable Cardioverter-defibrillator Eligibility in Patients With Arrhythmogenic Right and Left Ventricular Cardiomyopathy: a Prospective Longitudinal Pilot Cohort Study
Run by University of Sao Paulo · NCT07849764 · Data updated 2026-11-12
This study checks whether adults with arrhythmogenic cardiomyopathy stay eligible for a subcutaneous ICD over 18 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | July 8, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07849764 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with ACM (ARVC or ALVC) at varying risk levels for sudden death and considered candidates for S-ICD screening.
✕Probably not a fit
Patients whose ACM progresses or who do not meet initial screening criteria may not benefit from S-ICD eligibility stability.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, longitudinal observational study evaluating long-term stability of S-ICD eligibility in adults with arrhythmogenic cardiomyopathy. Participants undergo periodic ECG screening to see if their heart signals remain suitable for subcutaneous ICD sensing as ACM progresses. The study also explores whether changes in ECG features correlate with eligibility changes. The aim is to understand how disease progression may impact the appropriateness of S-ICD therapy in this population.
Why it matters
Potential benefit: If eligibility remains stable, patients may have a reliable path to S-ICD protection with potentially fewer lead-related complications.
How similar studies have gone: There is limited long-term data on S-ICD eligibility stability in ACM, making this study relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Heart Institute
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Luciana Sacilotto, MD, PhD
- Email: lu.sacilotto@gmail.com
- Phone: 551126615342
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.