IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

Inclusion Criteria

• Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment.
• Diagnosis of paroxysmal atrial fibrillation defined as symptomatic paroxysmal AF with at least two episodes of paroxysmal AF observed within the 12 months preceding inclusion.
• Patients are resistant to anti-arrhythmic treatments.
• Anteroposterior Left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure.
• Subject has no contraindications to intraoperative transesophageal echocardiography;
• Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) to be performed including open-heart surgery for one or more of the following:
• Mitral valve repair or replacement,
• Aortic valve repair or replacement
• Tricuspid valve repair or replacement, or
• Coronary artery bypass procedures
• Left ventricular ejection fraction ≥40% as documented by TTE within 12 months prior to the procedure.
• Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by trial investigators.
• Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-ups associated with this clinical trial.

Exclusion Criteria

• Abnormal cardiac and/or epicardial anatomy (such as adhesion, anomalous coronaries, thickened epicardium, etc.) or pericardial reflections on TTE, MRI or CT.
• Prior left-sided cardiac ablation.
• Prior history of open chest surgery and/or any procedure where the pericardial space was entered or instrumented (pericardiocentesis, catheter mapping and /or ablation).
• Patient has a prosthetic heart valve.
• Patient has a left atrial appendage device
• Prior history of pericarditis or pericarditis within 3 months based on the TTE examination.
• Subject is a woman of child bearing age
• Prior history of rheumatic fever.
• Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, Atrial septal defect) ASD closure, left atrial appendage occlusion)
• History of severe chronic gastrointenstinal problems involving the esophagus, stomach and/or untreated acid reflux
• History of abnormal bleeding and/or clotting disorder.
• Active malignancy or history of treated cancer within 24 months of enrollment.
• Clinically significant infection or sepsis.
• History of stroke or TIA within prior 6 months
• New York heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment.
• Body mass index > 35.
• Estimate glomerular filtration rate (eGFR) 50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease.
• Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder).
• Life expectancy less than one year.
• Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
• Enrolled in another cardiac clinical trial that would interfere with this trial.
• Life expectancy less than one year.
• Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
• Enrolled in another cardiac clinical trial that would interfere with this trial.