Subcutaneous ICD Eligibility Over Time in Arrhythmogenic Cardiomyopathy

NCT07849764 | Recruiting

• 2 other identifiers: 98034926.8.0000.00688.499.814
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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 changes in eligibility related to changes in the electrocardiogram during follow-up? Researchers will compare patients with arrhythmogenic cardiomyopathy with patients with Brugada syndrome, a condition in which the S-ICD is commonly used, and with people without structural heart disease. Participants will:
• Undergo S-ICD screening using the manufacturer's screening algorithm, with electrodes placed on the chest skin, at the start of the study and again at 6, 12 and 18 months
• Continue their usual medical care No device will be implanted as part of this study. Any decision to implant a defibrillator will be made by each patient's care team, independently of the study.

Conditions

Arrhythmogenic Cardiomyopathy

Keywords

Arrhythmogenic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Stability of subcutaneous ICD eligibility over 18 months

  Proportion of patients with arrhythmogenic cardiomyopathy who are eligible for a subcutaneous implantable cardioverter-defibrillator at each assessment, and proportion of those eligible at baseline who remain eligible during follow-up. Eligibility is determined by surface ECG screening using the manufacturer's screening algorithm.

  Baseline, 6, 12 and 18 months

Secondary Outcomes (1)

• Association between ECG changes and subcutaneous ICD eligibility at 18 months

  Baseline to 18 months

Other Outcomes (4)

• Number of eligible sensing vectors

  Baseline, 6, 12 and 18 months

• Eligibility according to electrode position

  Baseline, 6, 12 and 18 months

• Comparison of subcutaneous ICD eligibility among study groups

  Baseline, 6, 12 and 18 months

Study Arms (3)

Arrhythmogenic cardiomyopathy

Adults with arrhythmogenic right ventricular cardiomyopathy (2010 Task Force criteria) or arrhythmogenic left ventricular cardiomyopathy (Padua criteria), with an indication for an implantable cardioverter-defibrillator for primary or secondary prevention of sudden cardiac death, followed at the Arrhythmia Clinical Unit of InCor.

Diagnostic Test: Subcutaneous ICD ECG screening

Brugada syndrome (reference group)

Adults with type 1 Brugada ECG pattern, spontaneous or drug-induced, a condition in which the subcutaneous ICD is commonly indicated.

Diagnostic Test: Subcutaneous ICD ECG screening

Control group

Adults without structural heart disease, defined by a normal transthoracic echocardiogram.

Diagnostic Test: Subcutaneous ICD ECG screening

Interventions

Subcutaneous ICD ECG screening DIAGNOSTIC_TEST

Surface ECG screening for subcutaneous implantable cardioverter-defibrillator eligibility using the manufacturer's screening algorithm, performed at baseline and at 6, 12 and 18 months. No device is implanted as part of the study.

Arrhythmogenic cardiomyopathy; Brugada syndrome (reference group); Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults followed at the Arrhythmia Clinical Unit of the Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil, in three groups: patients with arrhythmogenic right or left ventricular cardiomyopathy; patients with Brugada syndrome, a condition in which the subcutaneous ICD is commonly indicated (reference group); and individuals without structural heart disease on transthoracic echocardiography (control group).

You may qualify if:

• 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)

You may not qualify if:

• 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
• Age 18 years or older
• Type 1 Brugada ECG pattern, spontaneous or drug-induced
• 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
• Age 18 years or older
• No structural heart disease, defined by a transthoracic echocardiogram with all parameters within normal reference values
• Structural heart disease on transthoracic echocardiography

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Central Study Contacts

Luciana Sacilotto, MD, PhD

CONTACT

551126615342; lu.sacilotto@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)