Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
∙ Study subjects are required to meet all the following inclusion criteria:
• Subjects with an age range of 18 years or above and 80 years or below.
• Subjects have symptomatic, drug-resistant, persistent AF, defined as:
‣ Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
⁃ Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
⁃ Persistent: continuous AF for \> 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
• Subjects undergoing a first-time ablation procedure for AF.
• Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.