Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies

NCT07688200 | Not Yet Recruiting

• 1 other identifier: TRACE-ACM-001
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of ventricular tachyarrhythmia episodes by arrhythmia type

  through study completion, an average of 1 year

• Number of ventricular arrhythmia episodes classified by initiation pattern

  through study completion, an average of 1 year

• Number of ventricular arrhythmia recurrences

  through study completion, an average of 1 year

• Number of ventricular arrhythmia episodes by autonomic pattern

  through study completion, an average of 1 year

• Number of appropriate ICD interventions

  through study completion, an average of 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Policlinico Casilino ASL RMB: lead

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Arrhythmogenic Right Ventricular Dysplasia; Tachycardia, Ventricular; Ventricular Fibrillation; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Cardiomyopathies; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Barca, MD

  Policlinico Casilino, Rome

  STUDY DIRECTOR

• Cinzia Crescenzi, MD

  Policlinico Casilino, Rome

  STUDY DIRECTOR

• Kristian Galanti, MD

  Policlinico Casilino, Rome

  STUDY DIRECTOR

• Alessandro Nudi, MD

  Policlinico Casilino, Rome

  STUDY DIRECTOR

Central Study Contacts

Leonardo Calò, MD

CONTACT

+39 3388589677; leonardocalo.doc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share