← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07688200). StuddyBuddy aggregates publicly available trial information.