Heart Team assessment of operability (the heart team considers the patient to be a good surgical candidate).
Evidence of an acute myocardial infarction = 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB = twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
Untreated, severe, left sided valvular heart disease including mitral regurgitation or stenosis, and aortic regurgitation or stenosis.
Mean pulmonary artery pressures =40mmHG and PVR >4 woods units as assessed by right heart catheterization.
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Examples of permanent implant would include any new heart valve. Implantation of a permanent pacemaker is excluded.
Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL).
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
Need for emergency surgery for any reason.
Left ventricular ejection fraction <40%.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Active upper GI bleeding within 3 months (90 days) prior to procedure.
A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
Recent CVA clinically confirmed (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
Estimated life expectancy < 1 year from conditions other than TR.
Expectation that patient will not improve despite treatment of tricuspid regurgitation
Currently participating in another investigational cardiac device study or any other clinical trial, including drugs or biologics. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
Active bacterial endocarditis within 6 months (180 days) of procedure.
Patients with signs or symptoms of SVC syndrome, or hepatic cirrhosis not felt due to passive congestion from TR.

NCT02339974_exc_T1
Condition
heart team considers the patient to be a good surgical candidate
NCT02339974_exc_T2
Procedure
Heart Team assessment of operability
NCT02339974_exc_T3
Condition
acute myocardial infarction
NCT02339974_exc_T4
Temporal
= 1 month (30 days) before the intended treatment
NCT02339974_exc_T5
Condition
valvular heart disease
NCT02339974_exc_T6
Qualifier
left sided
NCT02339974_exc_T7
Qualifier
severe
NCT02339974_exc_T8
Qualifier
Untreated
NCT02339974_exc_T9
Condition
mitral regurgitation
NCT02339974_exc_T10
Condition
tral r enosis,
NCT02339974_exc_T11
Condition
aortic regurgitation
NCT02339974_exc_T12
Condition
rtic r enosis.
NCT02339974_exc_T13
Scope
mitral regurgitation or stenosis, and aortic regurgitation or stenosis
NCT02339974_exc_T14
Measurement
Mean pulmonary artery pressures
NCT02339974_exc_T15
Value
=40mmHG
NCT02339974_exc_T16
Measurement
PVR
NCT02339974_exc_T17
Value
>4 woods units
NCT02339974_exc_T18
Condition
right heart catheterization
NCT02339974_exc_T19
Scope
Mean pulmonary artery pressures =40mmHG and PVR >4 woods units
NCT02339974_exc_T20
Procedure
cardiac procedure
NCT02339974_exc_T21
Qualifier
invasive
NCT02339974_exc_T22
Qualifier
therapeutic
NCT02339974_exc_T23
Device
permanent implant
NCT02339974_exc_T24
Temporal
within 30 days of the index procedure
NCT02339974_exc_T25
Reference_point
the index procedure
NCT02339974_exc_T26
Device
heart valve
NCT02339974_exc_T27
Device
permanent pacemaker
NCT02339974_exc_T28
Negation
excluded
NCT02339974_exc_T29
Procedure
cal or t ion for
NCT02339974_exc_T30
Procedure
transcatheter ablation
NCT02339974_exc_T31
Condition
Atrial Fibrillation
NCT02339974_exc_T32
Mood
planned
NCT02339974_exc_T33
Temporal
concomitant
NCT02339974_exc_T34
Scope
surgical or transcatheter ablation
NCT02339974_exc_T35
Condition
Leukopenia
NCT02339974_exc_T36
Measurement
WBC
NCT02339974_exc_T37
Value
< 3000 cell/mL
NCT02339974_exc_T38
Condition
acute anemia
NCT02339974_exc_T39
Measurement
Hgb
NCT02339974_exc_T40
Value
< 9 g/dL
NCT02339974_exc_T41
Condition
Thrombocytopenia
NCT02339974_exc_T42
Measurement
Plt
NCT02339974_exc_T43
Value
< 50,000 cell/mL
NCT02339974_exc_T44
Condition
respiratory instability
NCT02339974_exc_T45
Procedure
inotropic support
NCT02339974_exc_T46
Condition
amic or res lity requir
NCT02339974_exc_T47
Procedure
mechanical ventilation
NCT02339974_exc_T48
Procedure
mechanical heart assistance
NCT02339974_exc_T49
Temporal
within 30 days of screening evaluation
NCT02339974_exc_T50
Reference_point
screening evaluation
NCT02339974_exc_T51
Scope
inotropic support, mechanical ventilation or mechanical heart assistance
NCT02339974_exc_T52
Scope
Hemodynamic or respiratory instability
NCT02339974_exc_T53
Procedure
emergency surgery
NCT02339974_exc_T54
Mood
Need for
NCT02339974_exc_T55
Measurement
Left ventricular ejection fraction
NCT02339974_exc_T56
Value
<40%
NCT02339974_exc_T57
Procedure
Echocardiographic
NCT02339974_exc_T58
Condition
intracardiac mass
NCT02339974_exc_T59
Condition
ac mass, thr r vegeta
NCT02339974_exc_T60
Condition
ac mass, thr .
Active u
NCT02339974_exc_T61
Scope
intracardiac mass, thrombus or vegetation
NCT02339974_exc_T62
Temporal
Active
NCT02339974_exc_T63
Condition
upper GI bleeding
NCT02339974_exc_T64
Temporal
within 3 months (90 days) prior to procedure
NCT02339974_exc_T65
Reference_point
procedure
NCT02339974_exc_T66
Condition
contraindication
NCT02339974_exc_T67
Condition
hypersensitivity
NCT02339974_exc_T68
Procedure
anticoagulation regimens
NCT02339974_exc_T69
Condition
inability
NCT02339974_exc_T70
Procedure
anticoagulated
NCT02339974_exc_T71
Temporal
for the study procedure
NCT02339974_exc_T72
Reference_point
study procedure
NCT02339974_exc_T73
Scope
contraindication or hypersensitivity
NCT02339974_exc_T74
Condition
CVA
NCT02339974_exc_T75
Procedure
neuroimaging
NCT02339974_exc_T76
Value
confirmed
NCT02339974_exc_T77
Condition
stroke
NCT02339974_exc_T78
Condition
transient ischemic attack (TIA)
NCT02339974_exc_T79
Scope
stroke or transient ischemic attack (TIA)
NCT02339974_exc_T80
Qualifier
clinically confirmed (by neurologist)
NCT02339974_exc_T81
Temporal
within 6 months (180 days) of the procedure
NCT02339974_exc_T82
Reference_point
the procedure
NCT02339974_exc_T83
Observation
Estimated life expectancy
NCT02339974_exc_T84
Value
< 1 year
NCT02339974_exc_T87
Condition
bacterial endocarditis
NCT02339974_exc_T88
Temporal
Active
NCT02339974_exc_T89
Temporal
within 6 months (180 days) of procedure
NCT02339974_exc_T90
Reference_point
of procedure
NCT02339974_exc_T91
Condition
SVC syndrome
NCT02339974_exc_T92
Condition
hepatic cirrhosis
NCT02339974_exc_T93
Condition
passive congestion from TR