| Eligibility |
Inclusion Criteria:
- Male or female between the ages of 18 to 80 years at time of consent.
- Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or
PerAF
- Willing and able to provide written informed consent to to participate in the study
and agree to comply with all follow-up visits and evaluations for the duration of the
study.
Exclusion Criteria:
- In the opinion of the investigator, any contraindication to the planned atrial
ablation, including anticoagulation contraindications or sepsis
- Continuous AF > 12-months (long-standing persistent AF)
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other
reversible or non-cardiac cause.
- An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
- Structural heart disease or cardiac history as described below:
- Left ventricular ejection fraction (LVEF) < 35% based on transthoracic echocardiogram
(TTE) within the previous 180-days.
- Left atrial size > 55 mm based on TTE within the previous 180-days.
- Evidence of heart failure (NYHA Class III or IV).
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for
coronary artery bypass).
- Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
- Coronary artery bypass graft (CABG) or coronary angioplasty (PTCA) procedure within
the last 90-days.
- Unstable angina or ongoing myocardial ischemia.
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic
pressure > 140 mm Hg recorded within the last 30-days.
- Moderate or severe tricuspid stenosis or regurgitation.
- Moderate or severe mitral stenosis or regurgitation.
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- Presence of a left atrial appendage occlusion device.
- Previous PV stenting or evidence of PV stenosis
- Body Mass Index (BMI) >40 kg/m2
- History of blood clotting or bleeding disease.
- Any prior history of documented cerebral infarct or systemic embolism (excluding post-
operative deep vein thrombosis (DVT)).
- Pregnant or lactating (current or anticipated during study follow up).
- Current enrollment in any other study protocol where testing or results from the study
may interfere with the procedure or outcome measurements for this study.
- Any other condition that, in the judgment of the investigator, makes the patient a
poor candidate for this procedure, the study or compliance with the protocol (includes
vulnerable patient population, mental illness, addictive disease, terminal illness
with a life expectancy of less than two years, extensive travel away from the research
center)
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