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NCT Number: NCT07688200

Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies

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.

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Key information

Conditions

Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Arrhythmias, Cardiac Arrhythmogenic Right Ventricular Dysplasia Cardiac Conduction System Disease Cardiomyopathies Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Arrest Heart Defects, Congenital Heart Diseases ICD ICD Malfunction ICD SHOCKS Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Arrhythmia Ventricular Arrhythmias and Cardiac Arrest Ventricular Fibrillation Ventricular Tachycardia (VT)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of participants with ICD-related complications

    Time frame: 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 outcomes

  1. Number of ventricular tachyarrhythmia episodes by arrhythmia type

    Time frame: 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.

  2. Number of ventricular arrhythmia episodes classified by initiation pattern

    Time frame: 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.

  3. Number of ventricular arrhythmia recurrences

    Time frame: 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.

  4. Number of ventricular arrhythmia episodes by autonomic pattern

    Time frame: 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.

  5. Number of appropriate ICD interventions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leonardo Calò, MD

CONTACT

[email protected]

+39 3388589677

Sponsors and collaborators

Lead sponsor

Policlinico Casilino ASL RMB

Other

Registry information

Official study title

Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies: A Multicenter Retrospective Observational Study

Acronym: TRACE-ACM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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