Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results for patients with PAF. However, results from previous studies about SVCI remain controversial. It is possible that safety concerns for SVCI outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution.
The goal of this prospective, randomized controlled trial is to test the efficacy and safety of quantitative SVCI in addition to PVI in PAF. Participants with PAF will be randomly assigned to either PVI group or PVI+ quantitative SVCI group in a 1:1 ratio and will be followed up for 12 months. The main questions it aims to answer are:
1. Evaluate the efficacy of PVI+SVCI guided by quantitative AI. 2. Assess the safety of PVI+SVCI guided by quantitative AI.
The primary end point is treatment success at 3 months after the index ablation. The secondary end points include treatment success at 12 months, and safety outcomes.
Symptomatic paroxysmal AF that are unresponsive to antiarrhythmic drugs (one or more than one).
Willing to undergo catheter ablation for AF.
Age: 40-75 years old.
History of any type of catheter ablation for cardiac arrhythmias.
History of any type of thoracic surgery, including cardiac surgery.
History of malignant tumors.
History of permanent pacemaker implantation.
Parallel
PVI
Procedure/Surgerypulmonary vein isolation
PVI+ quantitative SVCI
Procedure/Surgerypulmonary vein isolation and superior vena cava isolation guided by quantitative ablation index
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 3 months follow-up
The proportion of patients that are freedom from AF, atrial flutter, or atrial tachycardia for longer than 30 seconds measured by 14-day Holter ECG at 3 months after the index ablation.
Proportion of patients with maintenance of sinus rhythm measured by 14-day Holter ECG at 12 months follow-up
The proportion of patients that are freedom from AF, atrial flutter, or atrial tachycardia for longer than 30 seconds measured by 14-day Holter ECG at 12 months after the index ablation.
Incidence of treatment emergent adverse events post ablation
Incidence of treatment emergent adverse events that include death, stroke/TIA, pericardial tamponade or effusion that requires drainage, pulmonary vein stenosis, superior vena cava stenosis, diaphragmatic nerve injury or paralysis, sinus node dysfunction, and atrial esophageal fistula.
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