Clinical Trials

Inclusion Criteria:

• Subject is greater than or equal to 18 years of age.
• Subject has history of persistent or long-standing persistent atrial fibrillation:
  • AF documentation requirement for persistent AF: Physician’s note indicating continuous AF > 7 days but no more than 1 year, and electrocardiographic documentation showing continuous AF within 90 days of the ablation procedure. Documentation can include a 24- hour holter (or equivalent) or two ECGs taken at least seven days apart within 90 days of the ablation procedure;
  • AF documentation requirement for longstanding persistent AF: physician’s note indicating at least 1 year of continuous AF, and electrocardiographic documentation showing continuous AF within 90 days of the ablation procedure. Documentation can include a 24- hour holter (or equivalent) or two ECGs taken at least seven days apart within 90 days of the ablation procedure. The performance of a successful cardioversion (sinus rhythm > 30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF within 30 days should not alter the classification of AF as long-standing persistent.
• Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass 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, Coronary artery bypass procedures, patent foramen ovale repair, and/or atrial septal defect.
• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
• Subject is willing and able to provide written informed consent.
• Subject has a life expectancy of at least 5-years.
• Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria:

• Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
• Previous surgical Maze procedure.
• Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, AV nodal reentry.
• Prior cardiac surgery (Redo).
• Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.
• Class IV NYHA heart failure symptoms.
• Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit.
• Documented ST elevation MI within the 6 weeks prior to study enrollment.
• Need for emergent cardiac surgery (i.e., cardiogenic shock).
• Known carotid artery stenosis greater than 80%.
• Documented (continuous) AF duration of greater than ten years.
• LA diameter > 7 cm by TTE within 12 weeks (90 days) of procedure.
• Current diagnosis of active systemic infection.
• Severe peripheral arterial occlusive disease defined as claudication with minimal exertion.
• Renal failure requiring dialysis or hepatic failure.
• A known drug and/or alcohol addiction.
• Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study.
• Pregnancy or desire to get pregnant within 12-months of the study treatment.
• Preoperative need for an intra-aortic balloon pump or intravenous inotropes.
• Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia.
• Subjects who have been treated with thoracic radiation.
• Subjects in current chemotherapy.
• Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases).
• Subjects with known connective tissue disorders.
• Subjects with known hypertrophic obstructive cardiomyopathy.
• Subjects with known cold agglutinin.
• Patient has a condition that in the opinion of the investigator, may jeopardize the patient’s wellbeing and/or the soundness of this clinical study.
• Subject has a contraindication to post-operative anticoagulation; Patient has history of blood dyscrasia or clotting disorder (i.e., Idiopathic Thrombocytopenic Purpura [ITP] or Thrombotic Thrombocytopenic Purpura [TTP]).

Eligibility last updated 9/21/21. Questions regarding updates should be directed to the study team contact.