Arrhythmogenic Cardiomyopathy (AC, ARVD/C), ICD, ICD Malfunction, ICD SHOCKS, Ventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia (VT)
Conditions
Keywords
Implantable cardioverter-defibrillator, ICD complications, Arrhythmogenic cardiomyopathy, Monomorphic ventricular tachycardia, Polymorphic ventricular tachycardia, Ventricular fibrillation, ICD electrograms, Arrhythmic storm, Pause-dependent arrhythmia initiation, Catheter ablation, Antiarrhythmic drugs
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
Policlinico Casilino ASL RMB
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with ICD-related complications | through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ventricular tachyarrhythmia episodes by arrhythmia type | through study completion, an average of 1 year | 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 | through study completion, an average of 1 year | 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 | through study completion, an average of 1 year | 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 | through study completion, an average of 1 year | Number of ventricular arrhythmia episodes classified according to available clinical circumstances suggestive of adrenergic or vagal predominance. |
| Number of appropriate ICD interventions | through study completion, an average of 1 year | Number of appropriate ICD interventions, including antitachycardia pacing and appropriate ICD shocks, delivered for ventricular arrhythmias during follow-up. |
Contacts
CONTACTLeonardo Calò, MD
STUDY_DIRECTORLuca Barca, MD
Policlinico Casilino, Rome
STUDY_DIRECTORCinzia Crescenzi, MD
Policlinico Casilino, Rome
STUDY_DIRECTORKristian Galanti, MD
Policlinico Casilino, Rome
STUDY_DIRECTORAlessandro Nudi, MD
Policlinico Casilino, Rome
Outcome results
None listed