Complex Arrhythmia Registry

Официальное название

Complex Arrhythmia Registry（CAR）： Long-term Outcomes of Catheter Ablation for Atrial Fibrillation or Ventricular Tachycardia： A Multicenter， Prospective Cohort Study

Обзор

This is a prospective, non-randomized, multicenter observational registry study designed to systematically evaluate the long-term efficacy and safety of catheter ablation for treating atrial fibrillation (AF) and ventricular tachycardia (VT) in Chinese patients.

Подробное описание

With the advancement of cardiac electrophysiology, the latest radiofrequency ablation technologies have played a significant role in the treatment of AF and VT. However, long-term outcome data on the application of these advanced techniques in Chinese patients still remains limited. The prospective, non-randomized, multicenter observational registry study will be divided into two cohorts:

1. The AF Cohort will focus on evaluating the effectiveness and safety of different ablation workflows. It aims to redefine the relationship between AF recurrence and long-term outcomes using AF burden, thereby further optimizing treatment strategies for AF. 2. The VT Cohort will primarily assess the application effects of novel technologies in VT treatment.

These data will provide critical reference information for future diagnostic and management strategies for complex arrhythmias.

Вмешательства

• Процедура AF ablation
  Catheter ablation will be performed under general anesthesia or local anesthesia. Pulmonary vein isolation (PVI) was performed in all patients. Beyond this mandatory step, the specific ablation strategy/protocol and ablation parameters/settings will be determined at the discretion of the operating physicians at each participating center.
• Процедура VT ablation
  For patients with hemodynamically stable VT, comprehensive chamber mapping (including activation mapping, substrate mapping, and entrainment mapping) is recommended. This aims to elucidate the VT activation sequence and identify the critical isthmus. Precise ablation targeting the isthmus should be performed to terminate the VT. For patients with hemodynamically unstable VT, substrate mapping during sinus rhythm can be performed first. This includes identification of low-voltage zones and abnorm

Первичные конечные точки

• Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 12-month follow-up [Срок оценки: 12 months]

Критерии участия

• Atrial Fibrillation (AF) Cohort:

• Inclusion Criteria (Patients must meet ALL of the following criteria):

• Age ≥ 18 years.
• Diagnosed with atrial fibrillation (AF), including paroxysmal AF (PAF) and persistent AF (PsAF).
• Scheduled to undergo first-time catheter ablation for AF.
• Procedure to be performed using a 3D mapping system.
• Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.
• Exclusion Criteria (Patients meeting ANY of the following criteria will be excluded):

• Severe congenital heart disease (e.g., Tetralogy of Fallot, corrected transposition of the great arteries).
• AF secondary to a clearly reversible cause (e.g., hyperthyroidism, post-operative state, acute alcohol intoxication).
• Unstable angina pectoris or acute myocardial infarction (MI) within 30 days prior to enrollment/procedure.
• Severe active infection (e.g., septic shock, sepsis).
• Contraindications to anticoagulation therapy.
• Current participation in another interventional clinical trial that may confound the results of this study.
• Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.
• Ventricular Tachycardia (VT) Cohort

• Inclusion Criteria (Patients must meet ALL of the following criteria):

• Age ≥ 18 years.
• Diagnosed with ventricular tachycardia (VT) associated with underlying structural heart disease, including:
• Ischemic heart disease (e.g., prior MI, coronary artery disease).
• Non-ischemic cardiomyopathy (e.g., dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM)).
• Scheduled to undergo first-time catheter ablation for VT.
• Procedure to be performed using a 3D mapping system.
• Provision of signed written informed consent for study participation and willingness and ability to comply with all protocol-required follow-up assessments.
• Exclusion Criteria (Patients meeting ANY of the following criteria will be excluded):

• VT due to a transient or reversible cause (e.g., acute myocardial ischemia, severe electrolyte imbalance).
• Idiopathic ventricular tachycardia (VT occurring in the absence of structural heart disease).
• Cardiac surgery within 60 days prior to the planned ablation procedure.
• Severe coagulopathy (e.g., platelet count < 50 x 10⁹/L, disseminated intravascular coagulation (DIC)).
• Severe heart failure with left ventricular ejection fraction (LVEF) < 20%.
• Severe active infection (e.g., septic shock, sepsis).
• Current participation in another interventional clinical trial that may confound the results of this study.
• Any other condition where, in the investigator's judgment, the patient is unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• No. 2 Anzhen Rd, Chaoyang District, 100029 — Пекин
• Beijing Anzhen Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07024927 · KS2025105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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