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.
Patients with arrhythmogenic cardiomyopathy will be identified at participating centers with expertise in the diagnosis and management of arrhythmogenic cardiomyopathies. De-identified retrospective data will be collected, including demographics, arrhythmogenic cardiomyopathy phenotype, genetic data, ICD type and indication, clinical follow-up, ICD therapies, antiarrhythmic and heart failure therapies, catheter ablation, and ECG/ICD electrogram documentation of ventricular tachyarrhythmias. ICD-related complications will include implant-related complications such as hematoma, perforation, pneumothorax, upper-limb deep vein thrombosis, lead failure, and infection, as well as non-implant-related complications such as inappropriate shocks. Ventricular arrhythmias will be classified as monomorphic ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation, or transition patterns between these arrhythmia types. When available, arrhythmia initiation will be analyzed using pre-specified ECG/EGM criteria including the origin of the beats preceding arrhythmia onset, R1-R2 and R2-R3 intervals, pause dependency, coupling interval, and prematurity index. The study will also describe atrial arrhythmias and medical, interventional, and device-based therapies adopted in this population, and will explore their relationship with ventricular arrhythmia recurrences and ICD interventions.
Study Type
OBSERVATIONAL
Enrollment
300
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.
Time frame: through study completion, an average of 1 year
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.
Time frame: through study completion, an average of 1 year
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.
Time frame: through study completion, an average of 1 year
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.
Time frame: through study completion, an average of 1 year
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.
Time frame: through study completion, an average of 1 year
Number of appropriate ICD interventions
Number of appropriate ICD interventions, including antitachycardia pacing and appropriate ICD shocks, delivered for ventricular arrhythmias during follow-up.
Time frame: through study completion, an average of 1 year
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