cellfx® nspfa™ cardiac surgery system to treat atrial fibrillation

Conditions: Atrial Fibrillation; Surgery

Summary: this feasibility study will be conducted to demonstrate the initial safety and effectiveness of the cellfx® nspfa™ cardiac clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.

this study is a prospective, multicenter, single arm, non-randomized, feasibility study. adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. all subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall

Eligibility criteria:
inclusion criteria: * subject must be between 18 and 85 years of age * subject is willing and capable of providing informed consent to undergo study procedures which includes surgical af ablation and completing follow-up visits as specified in the clinical study protocol * subject has history of documented atrial fibrillation within one year prior to enrollment. documentation may include ecg, transtelephonic monitor (ttm), holter monitor or telemetry strip * subject 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, ascending aortic aneurysms, or coronary artery bypass procedures * left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history) * subject has a life expectancy of at least 5 years exclusion criteria: * subject has an implantable electronic medical device. (i.e., pacemaker, icd or crt) or left atrial appendage device * subject has a prosthetic heart valve * stand-alone af without indication(s) for concomitant coronary artery bypass graft (cabg) and/or valve surgery * previous surgical maze procedure * prior cardiac surgery (redo) * wolff-parkinson-white syndrome or other supra-ventricular arrhythmia, atrioventricular (av) nodal reentry * subjects requiring surgery other than cabg and/or cardiac valve surgery and/or atrial septal defect repair. * prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation) * class iv new york heart association (nyha) heart failure symptoms * prior history of cerebrovascular accident or tia within 6 months or at any time if there is residual neurological deficit * documented st-segment elevation myocardial infarction (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% * 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 * 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 hypertrophic obstructive cardiomyopathy * subjects with known cold agglutinin * history of abnormal bleeding and/or clotting disorder * contraindication to anticoagulation (i.e., heparin, dabigatran, apixaban, vitamin k antagonists such as warfarin) * solid organ or hematologic transplant, or currently being evaluated for an organ transplant * body mass index \> 40 kg/m2 * use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study

Keywords: cellfx nspfa cardiac surgery system