Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats

Exclusion Criteria

• •1. History of non-paroxysmal AF less than 3 months or for more than 5 years;
• •2. History of prior cardiac ablative surgical or catheter-based therapy;
• •3. Previous cardiac surgery (redo) or other intrapericardial procedures;
• •4. Class IV NYHA heart failure;
• •5. Known carotid artery stenosis greater than 80% or previous carotid endarterectomy;
• •6. Wolff-Parkinson-White syndrome;
• •7. Need for emergent cardiac surgery (e.g., cardiogenic shock);
• •8. Untreated hyperthyroidism;
• •9. Untreated hypothyroidism;
• •10. Acute pulmonary disease;
• •11. Electrolyte imbalance;
• •12. History of myocarditis;
• •13. Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy (e.g., valvular prosthesis or ring, pacemaker with leads in coronary sinus or internal defibrillator leads);
• •14. History of pericarditis;
• •15. Previous left phrenic nerve paralysis;
• •16. Bullous lung disease;
• •17. Presence of active endocarditis, or local or systemic infection;
• •18. Recent myocardial infarction (\< 3 months);
• •19. Renal failure requiring dialysis or hepatic failure or creatinine of \>2 mg/dL preoperatively;
• •20. Antiarrhythmic drug therapy required for the treatment of a ventricular arrhythmia;
• •21. Preoperative need for an intra-aortic balloon pump or intravenous inotropes;
• •22. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion;
• •23. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders;
• •24. Documented left atrial size of 6 cm or more;
• •25. History of cerebrovascular disease or accident, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment;
• •26. Known contraindication to anticoagulant therapy or inability to comply with anticoagulant therapy;
• •27. Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
• •28. Forced expiratory volume in 1 second less than 30% of predicted value or need for home oxygen therapy; or
• •29. Surgical management of hypertrophic obstructive cardiomyopathy.