Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies: A Multicenter Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Number of participants with ICD-related complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of participants with ICD-related complications
时间窗: 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.
次要结局
- 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)
研究者
Leonardo Calò, MD
Principal Investigator
Policlinico Casilino ASL RMB