Clinical trial NCT07024927: Complex Arrhythmia Registry
Official title: Complex Arrhythmia Registry（CAR）： Long-term Outcomes of Catheter Ablation for Atrial Fibrillation or Ventricular Tachycardia： A Multicenter， Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Ventricular Tachycardia (VT)
Keywords: atrial fibrillation
ventricular tachycardia
ablation
registry study
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 4,000 patients who first undergo ablation will be included and divided into three cohorts: 1,000 in the PAF cohort, 2,000 in the PeAF cohort, and 1,000 in the organic VT cohort.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 1. Atrial Fibrillation (AF) Cohort:

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

     1. Age ≥ 18 years.
     2. Diagnosed with atrial fibrillation (AF), including paroxysmal AF (PAF) and persistent AF (PsAF).
     3. Scheduled to undergo first-time catheter ablation for AF.
     4. Procedure to be performed using a 3D mapping system.
     5. 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):

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

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

     1. Age ≥ 18 years.
     2. Diagnosed with ventricular tachycardia (VT) associated with underlying structural heart disease, including:
     3. Ischemic heart disease (e.g., prior MI, coronary artery disease).
     4. Non-ischemic cardiomyopathy (e.g., dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy (HCM)).
     5. Scheduled to undergo first-time catheter ablation for VT.
     6. Procedure to be performed using a 3D mapping system.
     7. 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):

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

Primary outcomes:
measure: Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
timeFrame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
measure: Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 12-month follow-up
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Deyong Long
role: PRINCIPAL_INVESTIGATOR
References: