Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation

Inclusion Criteria:

• • History of recurrent symptomatic PAF with ≥1 episode reported and documented withinthe 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 secondsin duration and terminate within 7 days.
• Refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker,Class I OR Class III anti-arrhythmic drug (AAD);
• Eligible for an ablation procedure with the Rhythmia HDx mapping system (softwareversion 2.0 or any future commercially available Software Version), IntellaMapOrion mapping catheter and IntellaNav MiFi OI ablation catheter according tocurrent international and local guidelines (and future revisions) and perphysician discretion;
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associatedwith this clinical investigation at an approved clinical investigational center;
• Age 18 to 80

Exclusion Criteria:

• • Diagnosed with any of the following heart conditions within 90 days (3 months) priorto enrollment:

1. New York Heart Association (NYHA) Class III or IV
2. Left ventricular ejection fraction (LVEF) <35%
3. Left atrial (LA) diameter >5.5 cm
4. Unstable angina or ongoing myocardial ischemia (OMI)
5. Transmural myocardial infarction (MI), acute coronary syndrome (ACS),percutaneous coronary intervention (PCI), or valve or coronary bypass graftingsurgery

• Active systemic infection or sepsis;
• Undergone any left atrial heart ablation procedure, either surgical orcatheter ablation
• Prosthetic or stenotic valves in the chamber where the intended mapping willoccur, or in the path of the catheter access route
• Subject has a Left Atrial Appendage Closure (LAAC) or PercutaneousTranscatheter Closure of a Patent Foramen Ovale (PFO)
• Subject has persistent or long-standing persistent atrial fibrillation (AF) ( >1 AF episodes lasting greater than 7 days, with no episodes having lastedgreater than 30 days, within the past year)
• Life expectancy ≤ 6 months per physician judgment
• Subjects who are currently enrolled in another investigational study orregistry that would directly interfere with the current study, except whenthe subject is participating in a mandatory governmental registry, or apurely observational registry with no associated treatments; each instancemust be brought to the attention of the sponsor to determine eligibility;
• The subject is unable or not willing to complete follow-up visits andexamination for the duration of the study;
• Women of childbearing potential who are, or plan to become, pregnant duringthe time of the study (method of assessment upon physician's discretion).