TRACE-ACM is a multicenter, retrospective, observational study of patients with arrhythmogenic cardiomyopathy who received an implantable cardioverter-defibrillator (ICD) and had documented ventricular tachyarrhythmias. The study aims to describe the prevalence and type of ICD-related complications, characterize ventricular arrhythmias documented by ICD electrograms and/or ECG recordings, and explore associations between clinical, device-related, and treatment-related factors and arrhythmic outcomes.
Diagnosis of arrhythmogenic cardiomyopathy, including right-dominant arrhythmogenic right ventricular cardiomyopathy, biventricular arrhythmogenic cardiomyopathy, or left-dominant arrhythmogenic left ventricular cardiomyopathy.
ICD implantation.
Documented sustained ventricular tachyarrhythmia, including polymorphic ventricular tachycardia, ventricular fibrillation, or monomorphic ventricular tachycardia.
Periodic clinical and ICD follow-up.
Incomplete ICD data or incomplete ICD follow-up.
Significant coronary artery disease, defined as coronary plaque greater than 50% at coronary angiography or coronary computed tomography angiography.
Primary valvular heart disease or congenital heart disease.
Infiltrative or inflammatory cardiomyopathies, including sarcoidosis or amyloidosis.
The study population includes patients with arrhythmogenic cardiomyopathy followed at participating expert centers who underwent implantable cardioverter-defibrillator implantation and had documented sustained ventricular tachyarrhythmias. Eligible patients may have right-dominant arrhythmogenic right ventricular cardiomyopathy, biventricular arrhythmogenic cardiomyopathy, or left-dominant arrhythmogenic left ventricular cardiomyopathy. Patients must have periodic clinical and ICD follow-up, with arrhythmia onset available from ICD electrograms and/or ECG recordings suitable for centralized analysis. Patients with significant coronary artery disease, primary valvular or congenital heart disease, infiltrative or inflammatory cardiomyopathies, or prior cardiotoxic therapy exposure are excluded.
Cohort
Retrospective
Not listed
Number of participants with ICD-related complications
Number of participants experiencing at least one ICD-related complication during follow-up, including implant-related complications such as hematoma, perforation, pneumothorax, upper-limb deep vein thrombosis, lead failure, and infection, and non-implant-related complications such as inappropriate shocks.
Number of ventricular tachyarrhythmia episodes by arrhythmia type
Number of documented ventricular tachyarrhythmia episodes classified as monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, ventricular fibrillation, or transition patterns between arrhythmia types.
Number of ventricular arrhythmia episodes classified by initiation pattern
Number of analyzable ventricular arrhythmia episodes classified according to pre-specified ECG or EGM initiation patterns, including type A and type B initiation, ventricular origin of preceding beats, pause dependency, coupling interval, and prematurity index.
Number of ventricular arrhythmia recurrences
Number of ventricular arrhythmia recurrences documented during follow-up after ICD implantation. Treatment exposure, including antiarrhythmic drug therapy, heart failure therapy, catheter ablation, and ICD programming strategy, will be recorded as baseline or follow-up clinical variables.
Number of ventricular arrhythmia episodes by autonomic pattern
Number of ventricular arrhythmia episodes classified according to available clinical circumstances suggestive of adrenergic or vagal predominance.
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