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NCT Number: NCT07024927

Complex Arrhythmia Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

No. 2 Anzhen Rd, Chaoyang District, 100029, Beijing, Beijing Municipality, China

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

  • 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.

Treatment and study plan

AF ablation

Procedure

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.

VT ablation

Procedure

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 abnormal electrograms (e.g., late potentials, local abnormal ventricular activities - LAVAs). Targeted substrate modification ablation should then be conducted based on the mapping findings. For all patients, complete substrate mapping is recommended after VT termination.

Primary outcomes

  1. Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure

    Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up

  2. Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 12-month follow-up

    Time frame: 12 months

    Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 12-month follow-up.

Study contacts

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

Deyong Long

CONTACT

[email protected]

+86 (010) 84005361

Deyong Long, MD

CONTACT

[email protected]

+86 (010) 84005361

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Acronym: CAR

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Jun 17, 2025
Registry last updated
Jun 4, 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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