๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
1. Atrial Fibrillation (AF) Cohort:
* Inclusion Criteria (Patients must meet ALL of the following criteria):
1. Age โฅ 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 โฅ 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 10โน/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.