Approved clinical indication for pectoral pacemaker exchange (e.g. elective replacement indication (ERI), end of service (EOS))
a single or dual chamber MRI conditional pacemaker (BSCI) or
Any comparable successor IPG (MRI conditional system, BSCI) compatible with
Implanted Fineline-II-leads (BSCI), MRI conditional
The ascertained lead impedance is between 200 and 1500 Ohm.
All pacing capture thresholds (PCT) do not exceed 2.0 V @0.4 or 0.5 ms in pacemaker dependent patients
Male or female 18 years or older
Understand the nature of the procedure
Give written informed consent
Able to complete all testing required by the clinical protocol
Ability to measure atrial and/or ventricular pacing threshold(s) at 0.4 or 0.5 ms
Patient body height greater or equal to 140 cm
Pectoral implanted device
Subjects who are able and willing to undergo elective cardiac magnetic resonance (MR) scanning without sedation (MRI-group)
Subjects who are geographically stable and available for follow-up at the study center for the length of the study

NCT02195024_inc_T3
Condition
elective replacement indication (ERI)
NCT02195024_inc_T4
Condition
end of service (EOS)
NCT02195024_inc_T5
Scope
elective replacement indication (ERI), end of service (EOS)
NCT02195024_inc_T1
Condition
clinical indication
NCT02195024_inc_T2
Procedure
pectoral pacemaker exchange
NCT02195024_inc_T6
Scope
clinical indication for pectoral pacemaker exchange
NCT02195024_inc_T7
Qualifier
ingle hamber
NCT02195024_inc_T8
Qualifier
dual chamber
NCT02195024_inc_T9
Scope
single or dual chamber
NCT02195024_inc_T10
Device
pacemaker
NCT02195024_inc_T11
Device
BSCI
NCT02195024_inc_T12
Scope
single or dual chamber MRI conditional pacemaker
NCT02195024_inc_T13
Device
MRI conditional system
NCT02195024_inc_T14
Device
BSCI
NCT02195024_inc_T15
Device
successor IPG
NCT02195024_inc_T16
Qualifier
comparable
NCT02195024_inc_T17
Scope
comparable successor IPG
NCT02195024_inc_T18
Scope
MRI conditional system, BSCI
NCT02195024_inc_T19
Device
Implanted Fineline-II-leads
NCT02195024_inc_T20
Device
BSCI
NCT02195024_inc_T21
Qualifier
MRI conditional
NCT02195024_inc_T22
Qualifier
MRI conditional
NCT02195024_inc_T23
Scope
Implanted Fineline-II-leads (BSCI)
NCT02195024_inc_T24
Measurement
ascertained lead impedance
NCT02195024_inc_T25
Value
between 200 and 1500 Ohm
NCT02195024_inc_T26
Measurement
pacing capture thresholds
NCT02195024_inc_T27
Measurement
PCT
NCT02195024_inc_T28
Value
do not exceed 2.0 V @0.4 or 0.5 ms
NCT02195024_inc_T29
Condition
pacemaker dependent
NCT02195024_inc_T30
Scope
pacing capture thresholds (PCT)
NCT02195024_inc_T31
Person
Male
NCT02195024_inc_T32
Person
female
NCT02195024_inc_T33
Value
18 years or older
NCT02195024_inc_T34
Person
years or older
NCT02195024_inc_T39
Measurement
body height
NCT02195024_inc_T40
Value
greater or equal to 140 cm
NCT02195024_inc_T41
Device
Pectoral implanted device
NCT02195024_inc_T42
Mood
willing to undergo
NCT02195024_inc_T43
Qualifier
elective
NCT02195024_inc_T44
Procedure
tic resonance (MR) scannin out seda
NCT02195024_inc_T45
Procedure
MR
NCT02195024_inc_T46
Qualifier
without sedation
NCT02195024_inc_T47
Person
geographically stable
NCT02195024_inc_T48
Observation
available for follow-up
NCT02195024_inc_T49
Visit
at the study center
NCT02195024_inc_T50
Temporal
for the length of the study
NCT02195024_inc_T51
Scope
geographically stable and available for follow-up
NCT02195024_inc_T52
Scope
at the study center for the length of the study