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Not Yet Recruiting NCT07688200

Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies

Conditions: Arrhythmogenic Cardiomyopathy (AC, ARVD/C), Ventricular Tachycardia (VT), Ventricular Fibrillation, ICD, ICD Malfunction, ICD SHOCKS, Ventricular Arrhythmias and Cardiac Arrest, Ventricular Arrhythmia

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Policlinico Casilino ASL RMB

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. * Arrhythmia onset available from ICD electrograms and/or ECG recordings. * ECG/EGM tracings available for analysis by the steering ECG committee. Exclusion Criteria: * 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. * Previous exposure to therapies associated with cardiac toxicity, including chemotherapy.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07688200). StuddyBuddy aggregates publicly available trial information.