Complex Arrhythmia Registry
Recruiting · NCT07024927 · Observational (researchers observe without assigning treatment) · Lead sponsor: Beijing Anzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
AF ablationVT ablation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- Beijing Anzhen Hospital, Capital Medical University - Beijing, China
- No. 2 Anzhen Rd, Chaoyang District, 100029 - Beijing, Beijing Municipality, China