CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

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.

Eligibility

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

Conditions5

Browse More Trials