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NCT07024927

Complex Arrhythmia Registry

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2025-07

Completion Date

2031-12

Last Updated

2025-06-17

Healthy Volunteers

Conditions

Atrial Fibrillation (AF)Ventricular Tachycardia (VT)

Interventions

PROCEDURE

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.

PROCEDURE

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 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.

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.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China