PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Trial Parameters
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Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria: 1. Subjects with an age range of 18 years or above and 80 years or below. 2. Subjects have symptomatic, drug-resistant, persistent AF, defined as: 1. Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath. 2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD. 3. 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. 3. Subjects undergoing a first-time ablation procedure for AF. 4. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study. Exclusion Criteria: 1. AF that is secondary to elect