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Keep this study
Lead
nContact Surgical Inc.
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation (AF) patients, using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster NaviStar® ThermoCool® Diagnostic/Ablation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age \> 18 years; \< 80 years
Left atrium less than or equal to 6.5 cm (TTE)
Symptomatic paroxysmal AF
Provided written informed consent
Refractory to at least one AAD (class I, II, III or IV)
You may not be if
Patients requiring concomitant surgery
Left ventricular ejection fraction \< 30%
Pregnant or planning to become pregnant during study
Co-morbid medical conditions that limit one year life expectancy
Measured left ventricular wall thickness \> 1.5 cm
History of coagulopathy
Previous cardiac surgery
Right ventricular outflow tract obstruction
History of pericarditis
Previous cerebrovascular accident (CVA), excluding fully resolved TIA
Patients who have severe chronic obstructive pulmonary disease (COPD)
Patients who have an active infection or sepsis
Patients who have uncorrected reversible cause(s) of AF
Patients who are contraindicated for anticoagulants
Patients who are being treated for arrhythmias other than AF
Patients who have had any previous AF or left atrial catheter ablation
Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
Clareo Health | Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
