Known or suspected sensitivity to Dexamethasone Acetate (DXA) 
Mechanical tricuspid heart valve 
Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following: 
Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits); 
RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject); 
Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations 
Currently on the active heart transplant list 
Documented life expectancy of less than 12 months 
Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion) 
Currently requiring chronic dialysis       
    

NCT01856491_exc_T1
Condition
sensitivity to Dexamethasone Acetate (DXA)
NCT01856491_exc_T2
Drug
Dexamethasone Acetate (DXA)
NCT01856491_exc_T3
Observation
suspected
NCT01856491_exc_T4
Observation
Known
NCT01856491_exc_T5
Scope
Known or suspected
NCT01856491_exc_T6
Device
Mechanical tricuspid heart valve
NCT01856491_exc_T15
Observation
active heart transplant list
NCT01856491_exc_T16
Observation
life expectancy
NCT01856491_exc_T17
Value
less than 12 months
NCT01856491_exc_T18
Condition
childbearing potential
NCT01856491_exc_T19
Person
Women
NCT01856491_exc_T20
Observation
are or might be
NCT01856491_exc_T22
Condition
pregnant
NCT01856491_exc_T23
Temporal
at the time of study enrollment
NCT01856491_exc_T21
Scope
Women of childbearing potential
NCT01856491_exc_T24
Procedure
chronic dialysis
NCT01856491_exc_T25
Condition
requiring chronic dialysis
NCT01856491_exc_T26
Temporal
Currently