Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
• History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AFib that terminates spontaneously or with intervention within seven days of onset. Minimum documentation includes a physician's note indicating recurrent self-terminating Atrial Fibrillation AND one electrocardiographically documented AF episode within 6 months prior to enrollment.
• Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines
• Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with a Boston Scientific Open-Irrigated Ablation Catheter according to current international and local guidelines
• Subjects who are willing and capable of providing informed consent
• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
• Subjects whose age is 20 years or above, or who are of legal age to give informed consent specific to state and national law.