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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with arrhythmogenic cardiomyopathy and ICD | Patients with arrhythmogenic cardiomyopathy, ICD implantation, and documented sustained ventricular tachyarrhythmias, with available ICD electrograms and/or ECG recordings suitable for analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonardo Calò, MD | Contact | +39 3388589677 | leonardocalo.doc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luca Barca, MD | Policlinico Casilino, Rome | Study Director |
| Cinzia Crescenzi, MD | Policlinico Casilino, Rome | Study Director |
| Kristian Galanti, MD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 1. Corrado D, Anastasakis A, Basso C, et al. Proposed diagnostic criteria for arrhythmogenic cardiomyopathy: European Task Force consensus report. Int J Cardiol. 2024;395:131447. doi:10.1016/j.ijcard.2023.131447. 2. Zeppenfeld K, Tfelt-Hansen J, de Riva M, et al. 2022 ESC Guidelines for ventricular arrhythmias and prevention of sudden cardiac death. Eur Heart J. 2022;43:3997-4126. doi:10.1093/eurheartj/ehac262. 3. Gasperetti A, James CA, Duru F, van Tintelen P, Calkins H. Arrhythmogenic right ventricular cardiomyopathy. Eur Heart J. 2026;ehag297. doi:10.1093/eurheartj/ehag297. 4. Arbelo E, Protonotarios A, Gimeno JR, et al. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023;44:3503-3626. 5. Towbin JA, McKenna WJ, Abrams DJ, et al. 2019 HRS expert consensus statement on arrhythmogenic cardiomyopathy. Heart Rhythm. 2019;16:e301-e372. doi:10.1016/j.hrthm.2019.05.007. 6. Christensen AH, Platonov PG, Svensson A, et al. Complications of implantable cardioverter-defibrillator treatment in arrhythmogenic right ventricular cardiomyopathy. Europace. 2022;24:306-312. 7. Migliore F, Pittorru R, De Lazzari M, et al. Third-generation subcutaneous ICD and intermuscular two-incision implantation in arrhythmogenic cardiomyopathy: 3-year follow-up. Int J Cardiol. 2023;382:33-39. 8. Belhassen B, Conte G, Steinberg C, et al. Mode and characteristics of arrhythmia initiation in idiopathic ventricular fibrillation: A THESIS substudy. JACC Clin Electrophysiol. 2024;10:1794-1809. 9. Gaine S, Rolland T, Asatryan B, et al. Long-term follow-up data on flecainide use as an antiarrhythmic in arrhythmogenic right ventricular cardiomyopathy. JACC Clin Electrophysiol. 2025;11:1159-1170. doi:10.1016/j.jacep.2025.02.023. |
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Individual participant data will not be publicly shared because the study includes retrospective clinical, device, ECG/EGM, and genetic data subject to privacy, ethical, and institutional restrictions. Aggregate study results may be shared through scientific presentations and peer-reviewed publications.
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| 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. |
| 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. | 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. | 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. | through study completion, an average of 1 year |
| Policlinico Casilino, Rome |
| Study Director |
| Alessandro Nudi, MD | Policlinico Casilino, Rome | Study Director |
| ID | Term |
|---|---|
| D019571 | Arrhythmogenic Right Ventricular Dysplasia |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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