Previous surgical or catheter ablation for atrial fibrillation
Previous cardiac surgery (including CABG) within the past 6 months (180 days)
Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
Any carotid stenting or endarterectomy
Documented LA thrombus on imaging
LA size > 50 mm (parasternal long axis view)
LVEF < 40%
Contraindication to anticoagulation (heparin or warfarin)
History of blood clotting or bleeding abnormalities
PCI/MI within the past 2 months (60 days)
Documented thromboembolic event (including TIA) within the past 12 months (365 days)
Rheumatic Heart Disease
Uncontrolled heart failure or NYHA function class III or IV
Severe mitral regurgitation (Regurgitant volume = 60 mL/beat, Regurgitant fraction = 50%, and/or Effective regurgitant orifice area = 0.40cm2)
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
Unstable angina
Acute illness or active systemic infection or sepsis
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Presence of implanted ICD/CRT-D.
Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including OTC medication)
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
Concurrent enrollment in an investigational study evaluating another device, biologic, or drug.
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes vascular access, or manipulation of the catheter.
Life expectancy less than 12 months

NCT03624881_exc_T1
Procedure
catheter ablation
NCT03624881_exc_T2
Procedure
ablation surgical
NCT03624881_exc_T3
Condition
atrial fibrillation
NCT03624881_exc_T4
Scope
surgical or catheter ablation
NCT03624881_exc_T5
Procedure
cardiac surgery
NCT03624881_exc_T6
Temporal
Previous
NCT03624881_exc_T7
Temporal
Previous
NCT03624881_exc_T8
Procedure
CABG
NCT03624881_exc_T9
Temporal
within the past 6 months (180 days)
NCT03624881_exc_T10
Procedure
lvular cardiac s rcutaneous procedure (
NCT03624881_exc_T11
Procedure
lvular cardiac surgical/p ocedure (
NCT03624881_exc_T12
Procedure
ventriculotomy
NCT03624881_exc_T13
Procedure
atriotomy
NCT03624881_exc_T14
Procedure
valve repair
NCT03624881_exc_T15
Procedure
lve r placement a
NCT03624881_exc_T16
Device
prosthetic valve
NCT03624881_exc_T17
Scope
ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve
NCT03624881_exc_T18
Scope
Valvular cardiac surgical/percutaneous procedure
NCT03624881_exc_T19
Device
carotid stenting
NCT03624881_exc_T20
Procedure
endarterectomy
NCT03624881_exc_T21
Condition
LA thrombus
NCT03624881_exc_T22
Procedure
imaging
NCT03624881_exc_T23
Measurement
LA size
NCT03624881_exc_T24
Value
> 50 mm
NCT03624881_exc_T25
Qualifier
parasternal long axis view
NCT03624881_exc_T26
Measurement
LVEF
NCT03624881_exc_T27
Value
< 40%
NCT03624881_exc_T28
Condition
Contraindication
NCT03624881_exc_T29
Drug
anticoagulation
NCT03624881_exc_T30
Drug
heparin
NCT03624881_exc_T31
Drug
warfarin
NCT03624881_exc_T32
Scope
heparin or warfarin
NCT03624881_exc_T33
Scope
Contraindication to anticoagulation
NCT03624881_exc_T34
Observation
History
NCT03624881_exc_T35
Condition
blood clotting
NCT03624881_exc_T36
Condition
bleeding abnormalities
NCT03624881_exc_T37
Scope
blood clotting or bleeding abnormalities
NCT03624881_exc_T38
Condition
MI
NCT03624881_exc_T39
Procedure
PCI
NCT03624881_exc_T40
Temporal
within the past 2 months
NCT03624881_exc_T41
Temporal
e past 2 months Documen
NCT03624881_exc_T42
Scope
within the past 2 months (60 days)
NCT03624881_exc_T43
Scope
PCI/MI
NCT03624881_exc_T44
Condition
thromboembolic event
NCT03624881_exc_T45
Condition
TIA
NCT03624881_exc_T46
Temporal
within the past 12 months
NCT03624881_exc_T47
Temporal
 past 12 month Rheumati
NCT03624881_exc_T48
Scope
within the past 12 months (365 days)
NCT03624881_exc_T49
Scope
thromboembolic event (including TIA)
NCT03624881_exc_T50
Condition
Rheumatic Heart Disease
NCT03624881_exc_T51
Qualifier
Uncontrolled
NCT03624881_exc_T52
Condition
heart failure
NCT03624881_exc_T53
Measurement
NYHA function class
NCT03624881_exc_T54
Value
III
NCT03624881_exc_T55
Value
IV
NCT03624881_exc_T56
Scope
III or IV
NCT03624881_exc_T57
Scope
NYHA function class III or IV
NCT03624881_exc_T58
Condition
mitral regurgitation
NCT03624881_exc_T59
Qualifier
Severe
NCT03624881_exc_T62
Measurement
Regurgitant volume
NCT03624881_exc_T63
Value
= 60 mL/beat
NCT03624881_exc_T60
Measurement
Regurgitant fraction
NCT03624881_exc_T61
Value
= 50%
NCT03624881_exc_T64
Measurement
Effective regurgitant orifice area
NCT03624881_exc_T65
Value
= 0.40cm2
NCT03624881_exc_T66
Scope
Regurgitant volume = 60 mL/beat, Regurgitant fraction = 50%, and/or Effective regurgitant orifice area = 0.40cm2
NCT03624881_exc_T67
Scope
Severe mitral regurgitation
NCT03624881_exc_T68
Procedure
cardiac transplantation
NCT03624881_exc_T69
Procedure
cardiac surgery
NCT03624881_exc_T70
Temporal
within the next 12 months
NCT03624881_exc_T71
Temporal
t 12 months (36 able ang
NCT03624881_exc_T72
Scope
cardiac transplantation or other cardiac surgery
NCT03624881_exc_T73
Condition
Unstable angina
NCT03624881_exc_T74
Condition
Acute illness
NCT03624881_exc_T75
Condition
systemic infection
NCT03624881_exc_T76
Qualifier
active
NCT03624881_exc_T77
Condition
sepsis
NCT03624881_exc_T78
Condition
AF
NCT03624881_exc_T79
Condition
electrolyte imbalance
NCT03624881_exc_T80
Qualifier
secondary
NCT03624881_exc_T81
Condition
thyroid disease
NCT03624881_exc_T82
Condition
non-cardiac cause
NCT03624881_exc_T83
Qualifier
reversible
NCT03624881_exc_T84
Device
implanted ICD/CRT-D
NCT03624881_exc_T85
Condition
pulmonary disease
NCT03624881_exc_T86
Qualifier
Significant
NCT03624881_exc_T87
Condition
restrictive pulmonary disease
NCT03624881_exc_T88
Condition
chronic obstructive pulmonary disease
NCT03624881_exc_T89
Condition
onic obstruc or any other dise
NCT03624881_exc_T90
Scope
restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease
NCT03624881_exc_T91
Scope
Significant pulmonary disease
NCT03624881_exc_T92
Qualifier
any other
NCT03624881_exc_T93
Condition
ion of piratory sys
NCT03624881_exc_T94
Condition
malfunction of the lungs
NCT03624881_exc_T95
Scope
disease or malfunction of the lungs or respiratory system
NCT03624881_exc_T96
Condition
ion of pirato that produces chro
NCT03624881_exc_T97
Condition
chronic symptoms
NCT03624881_exc_T98
Condition
Gastroesophageal Reflux Disease
NCT03624881_exc_T99
Condition
GERD
NCT03624881_exc_T100
Procedure
significant intervention
NCT03624881_exc_T101
Drug
OTC medication
NCT03624881_exc_T102
Negation
not
NCT03624881_exc_T103
Condition
congenital anomaly
NCT03624881_exc_T104
Qualifier
Significant
NCT03624881_exc_T105
Condition
medical problem
NCT03624881_exc_T107
Person
Women
NCT03624881_exc_T108
Condition
pregnant
NCT03624881_exc_T109
Procedure
pregnancy test
NCT03624881_exc_T110
Condition
pre-menopausal
NCT03624881_exc_T112
Condition
intracardiac thrombus
NCT03624881_exc_T113
Condition
myxoma
NCT03624881_exc_T114
Condition
tumor
NCT03624881_exc_T115
Condition
interatrial baffle
NCT03624881_exc_T116
Device
patch
NCT03624881_exc_T117
Qualifier
other
NCT03624881_exc_T118
Condition
abnormality
NCT03624881_exc_T119
Procedure
vascular access
NCT03624881_exc_T120
Procedure
manipulation of the catheter
NCT03624881_exc_T121
Condition
precludes
NCT03624881_exc_T122
Scope
vascular access, or manipulation of the catheter
NCT03624881_exc_T123
Observation
Life expectancy
NCT03624881_exc_T124
Value
less than 12 months