Trial Outcomes & Findings for The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF). (NCT NCT02671903)
NCT ID: NCT02671903
Last Updated: 2025-02-04
Results Overview
Measured using peak oxygen uptake (VO2).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
Baseline, 6 months and 12 months post randomisation.
Results posted on
2025-02-04
Participant Flow
Patients have a pacemaker device implanted and are subject to a 2-month run-in phase prior to randomisation.
Participant milestones
| Measure |
Arm A: Pacing Followed by No-Pacing
Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.
See below intervention details.
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
Arm B: No-Pacing Followed by Pacing
Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.
See below intervention details.
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
Run-In Phase (Pre-Randomisation)
2-month run-in period for ALL patients post implantation of pacemaker. Set at No-Pacing.
|
|---|---|---|---|
|
Period 0 (Run-In)
STARTED
|
0
|
0
|
183
|
|
Period 0 (Run-In)
COMPLETED
|
0
|
0
|
167
|
|
Period 0 (Run-In)
NOT COMPLETED
|
0
|
0
|
16
|
|
Period 1 (Month 0 to Month 6)
STARTED
|
83
|
84
|
0
|
|
Period 1 (Month 0 to Month 6)
COMPLETED
|
73
|
77
|
0
|
|
Period 1 (Month 0 to Month 6)
NOT COMPLETED
|
10
|
7
|
0
|
|
Period 2 (Month 6 to Month 12)
STARTED
|
73
|
77
|
0
|
|
Period 2 (Month 6 to Month 12)
COMPLETED
|
67
|
69
|
0
|
|
Period 2 (Month 6 to Month 12)
NOT COMPLETED
|
6
|
8
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Pacing Followed by No-Pacing
Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.
See below intervention details.
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
Arm B: No-Pacing Followed by Pacing
Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.
See below intervention details.
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
Run-In Phase (Pre-Randomisation)
2-month run-in period for ALL patients post implantation of pacemaker. Set at No-Pacing.
|
|---|---|---|---|
|
Period 0 (Run-In)
Death
|
0
|
0
|
3
|
|
Period 0 (Run-In)
Physician Decision
|
0
|
0
|
4
|
|
Period 0 (Run-In)
Withdrawal by Subject
|
0
|
0
|
4
|
|
Period 0 (Run-In)
Protocol Violation
|
0
|
0
|
1
|
|
Period 0 (Run-In)
Adverse Event
|
0
|
0
|
1
|
|
Period 0 (Run-In)
Implantation Failure
|
0
|
0
|
2
|
|
Period 0 (Run-In)
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF).
Baseline characteristics by cohort
| Measure |
Arm A: Pacing Followed by No-Pacing
n=83 Participants
Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing.
See below intervention details.
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
Arm B: No-Pacing Followed by Pacing
n=84 Participants
Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing.
See below intervention details.
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 10.19 • n=7 Participants
|
69.0 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other Ethnic Group
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
68 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Weight
|
85.22 kg
STANDARD_DEVIATION 16.788 • n=5 Participants
|
89.24 kg
STANDARD_DEVIATION 17.636 • n=7 Participants
|
87.24 kg
STANDARD_DEVIATION 17.286 • n=5 Participants
|
|
BMI
|
28.498 kg/m^2
STANDARD_DEVIATION 5.0208 • n=5 Participants
|
29.665 kg/m^2
STANDARD_DEVIATION 5.5027 • n=7 Participants
|
29.085 kg/m^2
STANDARD_DEVIATION 5.2853 • n=5 Participants
|
|
Diastolic BP
|
69.0 mmHg
STANDARD_DEVIATION 11.22 • n=5 Participants
|
70.8 mmHg
STANDARD_DEVIATION 11.31 • n=7 Participants
|
69.9 mmHg
STANDARD_DEVIATION 11.26 • n=5 Participants
|
|
Systolic BP
|
121.3 mmHg
STANDARD_DEVIATION 19.07 • n=5 Participants
|
121.7 mmHg
STANDARD_DEVIATION 20.24 • n=7 Participants
|
121.5 mmHg
STANDARD_DEVIATION 19.61 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT
Measured using peak oxygen uptake (VO2).
Outcome measures
| Measure |
Pacing
n=167 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=167 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Exercise Capacity.
|
14.0 ml/min/kg
Interval 13.0 to 15.0
|
13.7 ml/min/kg
Interval 12.8 to 14.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT Population
Measured during echocardiogram.
Outcome measures
| Measure |
Pacing
n=167 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=167 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction)
|
33.4 % (LVEF)
Interval 31.2 to 35.7
|
33.0 % (LVEF)
Interval 31.0 to 34.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT
Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation
Outcome measures
| Measure |
Pacing
n=167 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=167 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in B-type Naturietic Peptide (BNP).
|
323 (ng/L)
Interval 242.0 to 431.0
|
335 (ng/L)
Interval 257.0 to 436.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT - Note that some patients were not able to be analysed due to providing no questionnaire data.
Measured using Minnesota Score obtained from the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Score range: 0 to 105, with higher scores indicating a worse outcome with more significant impairment in health-related quality of life
Outcome measures
| Measure |
Pacing
n=151 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=151 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Quality of Life Scores. - Minnesota
|
30.9 scores on a scale
Interval 25.1 to 36.7
|
34.6 scores on a scale
Interval 29.8 to 39.3
|
SECONDARY outcome
Timeframe: Baseline.Population: NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed
The analysis will be based on an intention-to-treat (ITT) principle. The economic evaluation will compare incremental costs and incremental outcomes of the direct His-bundle pacing against the standard medical care. The study will be performed from a societal perspective, which takes all relevant cost-categories and effects into account. The economic evaluation will consist of two parts, a cost-effectiveness analysis (CEA) and a cost utility analysis (CUA). In the CEA the incremental cost-effectiveness ratio (ICER) will be expressed as the incremental costs per point improvement in exercise capacity in peak VO2. The primary outcome measure in the CUA will be Qualitative Adjusted Life Years (QALYs), based on the EQ5D and Minnesota questionnaire scores. NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. Outcome is based on when participants are on Pacing therapy and as such a per-protocol analysis would read zero for any period when not on pacing.
Measured at completion of periods 1 \& 2 (M6 \& M12) - Percentage of time where device recorded ventricular pacing during each treatment period. Values are recorded across both arms. Results are descriptive and displayed by treatment and by period.
Outcome measures
| Measure |
Pacing
n=83 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=84 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Percentage Pacing
M6
|
90.8 % (of time over period)
Standard Deviation 19.42
|
0 % (of time over period)
Standard Deviation 0
|
|
Changes in Percentage Pacing
M12
|
1.4 % (of time over period)
Standard Deviation 11.59
|
93.5 % (of time over period)
Standard Deviation 16.48
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint.
Measured upon completion of run-in (as baseline) and periods 1 \& 2 (M6 \& M12). Device detected Atrial Fibrillation/Supraventricular Tachycardia (AF/SVT) burden recorded as a percentage of time over the 6-month treatment period. Results are descriptive and displayed by treatment and by period.
Outcome measures
| Measure |
Pacing
n=83 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=84 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Arrythmia Burden (%).
BL (Randomisation)
|
0.1 % (time under AF/SVT burden)
Standard Deviation 0.52
|
0.3 % (time under AF/SVT burden)
Standard Deviation 2.40
|
|
Changes in Arrythmia Burden (%).
M6
|
0.2 % (time under AF/SVT burden)
Standard Deviation 0.62
|
0.1 % (time under AF/SVT burden)
Standard Deviation 0.46
|
|
Changes in Arrythmia Burden (%).
M12
|
0.4 % (time under AF/SVT burden)
Standard Deviation 2.01
|
1.5 % (time under AF/SVT burden)
Standard Deviation 11.87
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. Outcome is based on when participants are on Pacing therapy and as such a per-protocol analysis would read zero for any period when not on pacing.
Measured upon completion of run-in and periods 1 \& 2 (BL, M6 \& M12) Results are descriptive and displayed by treatment and by period. Please also note that voltage is presented for both RA Lead and LV Lead.
Outcome measures
| Measure |
Pacing
n=83 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=84 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Pacing Thresholds (Volts).
RA Lead - M6
|
0.82 Volts
Standard Deviation 1.090
|
0.74 Volts
Standard Deviation 0.645
|
|
Changes in Pacing Thresholds (Volts).
RA Lead - M12
|
0.78 Volts
Standard Deviation 1.034
|
0.79 Volts
Standard Deviation 0.938
|
|
Changes in Pacing Thresholds (Volts).
LV Lead - BL
|
0.78 Volts
Standard Deviation 0.438
|
0.84 Volts
Standard Deviation 0.516
|
|
Changes in Pacing Thresholds (Volts).
LV Lead - M12
|
0.78 Volts
Standard Deviation 0.359
|
0.76 Volts
Standard Deviation 0.280
|
|
Changes in Pacing Thresholds (Volts).
RA Lead - BL
|
0.82 Volts
Standard Deviation 0.972
|
0.78 Volts
Standard Deviation 0.510
|
|
Changes in Pacing Thresholds (Volts).
LV Lead - M6
|
0.78 Volts
Standard Deviation 0.452
|
0.73 Volts
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: Null analysis population as r-wave data was unable to be collected
Measured from electrocardiogram (ECG).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: \- Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint.
Measured upon completion of run-in and periods 1 \& 2 (BL, M6 \& M12). Results are descriptive and displayed by treatment and by period. Please also note that lead impedance is presented for both RA Lead, HIS-Lead and LV Lead.
Outcome measures
| Measure |
Pacing
n=83 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=84 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Lead Impedance (Ohms).
RA Lead Impedance - BL
|
460.8 ohms
Standard Deviation 66.7
|
480.8 ohms
Standard Deviation 89.24
|
|
Changes in Lead Impedance (Ohms).
RA Lead Impedance - M12
|
452.0 ohms
Standard Deviation 68.38
|
473.7 ohms
Standard Deviation 110.6
|
|
Changes in Lead Impedance (Ohms).
His Lead Impedance - BL
|
377.9 ohms
Standard Deviation 104.28
|
392.4 ohms
Standard Deviation 97.94
|
|
Changes in Lead Impedance (Ohms).
LV Lead Impedance - M6
|
427.8 ohms
Standard Deviation 87.01
|
439.1 ohms
Standard Deviation 109.44
|
|
Changes in Lead Impedance (Ohms).
LVLead Impedance - M12
|
425.8 ohms
Standard Deviation 85.06
|
431.2 ohms
Standard Deviation 9.02
|
|
Changes in Lead Impedance (Ohms).
RA Lead Impedance - M6
|
475.2 ohms
Standard Deviation 62.44
|
469.1 ohms
Standard Deviation 86.48
|
|
Changes in Lead Impedance (Ohms).
His Lead Impedance - M6
|
326.3 ohms
Standard Deviation 84.24
|
326.8 ohms
Standard Deviation 87.08
|
|
Changes in Lead Impedance (Ohms).
His Lead Impedance - M12
|
324.9 ohms
Standard Deviation 87.08
|
330.6 ohms
Standard Deviation 82.68
|
|
Changes in Lead Impedance (Ohms).
LV Lead Impedance - BL
|
436.5 ohms
Standard Deviation 90.85
|
464.8 ohms
Standard Deviation 101.62
|
SECONDARY outcome
Timeframe: Taken at Device Insertion Visit (2). Baseline measure.Population: ITT - Note that 2 patients (1 in each arm) have missing data. This outcome measure is only based on the device insertion and does not have a cross-over element.
Measured by time in minutes.
Outcome measures
| Measure |
Pacing
n=82 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=83 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Fluoroscopy Time During Device Insertion.
|
16.5 minutes
Interval 10.0 to 27.0
|
16.0 minutes
Interval 10.0 to 26.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 months post randomisation.Population: ITT - Note that some patients were not able to be analysed due to providing no questionnaire data.
Taken from the Visual Analog Scale (VAS) Score from EQ5D Health State Question in EuroQol, 5-dimension, 5-level (EQ5D5L) questionnaire. Score is on a 0-100 scale with 100 representing a better outcome for patients health state.
Outcome measures
| Measure |
Pacing
n=151 Participants
Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
|
No-Pacing
n=151 Participants
No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.
|
|---|---|---|
|
Changes in Quality of Life Scores. - EQ5D Health State Score
|
66.3 scores on a scale
Interval 61.0 to 71.6
|
64.3 scores on a scale
Interval 60.4 to 68.3
|
Adverse Events
Run-in Period (Pre-Randomisation)
Serious events: 25 serious events
Other events: 54 other events
Deaths: 0 deaths
AV Optimised Direct His-bundle (ARM A at Period 1, ARM B at Period 2)
Serious events: 25 serious events
Other events: 75 other events
Deaths: 6 deaths
No Pacing (ARM A at Period 2, ARM B at Period 1)
Serious events: 20 serious events
Other events: 75 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Run-in Period (Pre-Randomisation)
n=167 participants at risk
2-month run-in period post device implantation. Device switched to no pacing during this period.
|
AV Optimised Direct His-bundle (ARM A at Period 1, ARM B at Period 2)
n=160 participants at risk
Adverse Events \& Mortality grouped by treatment received over the 12-month follow-up period. AV optimised direct His-bundle (ARM A at Period 1, ARM B at Period 2).
Note: Due to withdrawals by period 2, total at risk for Pacing treatment = 160
|
No Pacing (ARM A at Period 2, ARM B at Period 1)
n=157 participants at risk
Adverse Events \& Mortality grouped by treatment received over the 12-month follow-up period. No Pacing (ARM A at Period 2, ARM B at Period 1)
Note: Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157
|
|---|---|---|---|
|
Cardiac disorders
Atrial tachycardia
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Acute pulmonary oedema and Aortic valve stenosis with insufficiency
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial arrhythmia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.9%
3/160 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Breathlessness
|
1.8%
3/167 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Cardiac Arrest
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Cardiogenic Shock
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
ICD trigger VF arrest
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Community Acquired Pneumonia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.2%
2/160 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Complete Heart Block
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Decompensated / Congestive Cardiac Failure
|
1.8%
3/167 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.9%
3/160 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
5.1%
8/157 • Number of events 8 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Exacerbation of Heart Failure
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
4.4%
7/160 • Number of events 7 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Ulcerated legs
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Fluid overload
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.2%
2/160 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Product Issues
His Lead displacement
|
3.0%
5/167 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Product Issues
ICD shock
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
LRTI
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Haematoma
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Immune system disorders
Anaphylactic Reaction
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Kidney Disease
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
AKI
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Raised His Lead Threshold
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Vascular disorders
Subclavian vein thrombosis.
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
VT Episodes
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
Other adverse events
| Measure |
Run-in Period (Pre-Randomisation)
n=167 participants at risk
2-month run-in period post device implantation. Device switched to no pacing during this period.
|
AV Optimised Direct His-bundle (ARM A at Period 1, ARM B at Period 2)
n=160 participants at risk
Adverse Events \& Mortality grouped by treatment received over the 12-month follow-up period. AV optimised direct His-bundle (ARM A at Period 1, ARM B at Period 2).
Note: Due to withdrawals by period 2, total at risk for Pacing treatment = 160
|
No Pacing (ARM A at Period 2, ARM B at Period 1)
n=157 participants at risk
Adverse Events \& Mortality grouped by treatment received over the 12-month follow-up period. No Pacing (ARM A at Period 2, ARM B at Period 1)
Note: Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157
|
|---|---|---|---|
|
Infections and infestations
Common Colds
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Endocrine disorders
abnormal blood sugar levels
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Hepatobiliary disorders
Abnormal LFTs
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Accidental morphine overdose
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Endocrine disorders
Acute Kidney Injury
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.2%
2/160 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial Fibrillation
|
3.6%
6/167 • Number of events 6 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
2.5%
4/160 • Number of events 4 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.2%
5/157 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial flutter
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial tachycardia
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg cramps
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Nervous system disorders
Bilateral numbness of arm when lying either side
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pleural Effusion
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Bloatedness
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Blocked urethral catheter
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Cardiac symptoms of palpitations and hypotension
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Chest Infection
|
1.8%
3/167 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
5.6%
9/160 • Number of events 12 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.8%
6/157 • Number of events 7 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Chest Pain
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.1%
5/160 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
2.5%
4/157 • Number of events 4 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.2%
2/160 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Decompensated Heart Failure
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Endocrine disorders
Diabetic Left Foot Ulcer
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Dizziness
|
2.4%
4/167 • Number of events 4 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Dry persistent cough
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Eczema Skin condition
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Exacerbation of HF
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.9%
3/160 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.2%
5/157 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Extreme tiredness and fatigue
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Fall secondary to dizziness
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Feeling of generally unwell
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Fever
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Fractured foot
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
2.5%
4/160 • Number of events 4 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Haematuria secondary to NOAC
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
HIS lead threshold rise
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Hospital Acquired Pneumonia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Hypergylcaemic Episode
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Hyperkalaemia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Idiopathic skin condition
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Ear and labyrinth disorders
Impacted ear wax
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Increased breathlessness
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.2%
5/157 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Intermittent cough
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Laceration to big toe
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Eye disorders
Left eye vitreous haemorrhage
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Left Kidney Stones
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Mechanical Fall
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
mouth ulcer requiring biopsy
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Endocrine disorders
New diagnosis of diabetes
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
nonblanching petechial rashes on both shins
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Non-sustained VT Episodes
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.8%
6/160 • Number of events 6 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.8%
6/157 • Number of events 6 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Painful bilateral knee
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
painful lower extremeties
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Palpitations
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Paroxysmal Atrial Fibrillation
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
2.5%
4/160 • Number of events 4 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.9%
3/157 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Polyps in colon
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
2.5%
4/157 • Number of events 4 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Progressive weight loss
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Raised His Lead Threshold
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Raised INR
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Received external electrical shock at work (works as an electrician)
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
recurrence of atrial arrhythmia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Recurrence of atrial fibrillation
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath, Productive cough and wheeze due to lower respiratory tract infection
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin cancer growth L) hand
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Sprained wrist due to fall
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
stomach pain
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Suspected lower respiratory tract infection
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Sustained VT treated with ATP
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Hepatobiliary disorders
swollen abdomen
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
swollen bilateral legs (knee to ankle)
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Swollen feet
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Swollen left arm secondary to blood clot
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Endocrine disorders
Thyroid Deficiency
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Tooth infection
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Urinary retention
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.2%
2/160 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.9%
3/160 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Ventricular Tachycardia Episodes
|
3.6%
6/167 • Number of events 6 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
3.1%
5/160 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Viral Illness of unknown origin
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Weight loss and dysphagia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Worsening chronic kidney disease
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Worsening renal function
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
worsening shortness of breath and activity tolerance
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath secondary to bilateral pleural effusion
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.62%
1/160 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
LRTI
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Anterior L1 Compression Fracture
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Bilateral swollen and painful legs
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Broken rib
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Surgical and medical procedures
Cataracts operation on left eye
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Product Issues
Coronary Sinus lead displaced
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
decreased activity tolerance and increased paroxysmal nocturnal dyspnea
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Degenerated rotator cuff and tendinopathy
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Psychiatric disorders
Depression
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Dislocated R shoulder due to mechanical fall
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Excessive intestinal gas -belching or flatulence
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Fainting spells
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Fall. Walking sticks slipped off.
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Fatigue
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Fracture in left elbow due to a fall
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Heavily trabeculated bladder with debris in urine noted during flexible cystoscopy
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Increased urinary frequency secondary to enlarged prostate
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
insertion of indwelling catheter
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Intermittent high impedance on His Lead with increase in His pacing threshold
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Late His Lead threshold rise
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Left leg cellulitis
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Left lower leg blister
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
left ventricular thrombus
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Lesion in caecum
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Renal and urinary disorders
Marked deterioration of kidney function
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Mild Infective Exacerbation of Bronchiectasis
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
MRSA positive nose and groin
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-tender pain free lump increasing in size
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Productive cough
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Recurrent Falls secondary to hypotension
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Progressive worsening of breathlessness
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
General disorders
Reduced mobility
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Right leg cellulitis
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Shoulder joint pain
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Slight palpitations, Chest discomfort.
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
ST elevation on ECG post MVO2
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Swollen right leg ?secondary to blood clot
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
TIA
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Nervous system disorders
Tingling sensation in both feet
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.64%
1/157 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
worsening shortness of breath
|
0.00%
0/167 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
1.3%
2/157 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Abscess
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Atrial Arrhythmia
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Investigations
Endoscopy
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Blood and lymphatic system disorders
Haematoma
|
3.0%
5/167 • Number of events 5 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Reproductive system and breast disorders
Penile pain
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Respiratory, thoracic and mediastinal disorders
URTI
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Vasovagal episode
|
1.2%
2/167 • Number of events 2 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Ventricular Ectopy burden
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Injury, poisoning and procedural complications
Injury due to Fall
|
1.8%
3/167 • Number of events 3 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Nervous system disorders
Headache
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
High atrial lead threshold
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Hypotension and dizziness
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Investigations
Mixed anaerobes in catheter swab
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Infections and infestations
Adverse chest findings following x-ray
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Investigations
Nitrites in Urine
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Investigations
Pseudomonas in urine
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Skin and subcutaneous tissue disorders
Seroma
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Product Issues
serous fluid found in old generator box site
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Pleural Effusion
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Cardiac disorders
Low QRS Duration
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
|
Musculoskeletal and connective tissue disorders
Pain and limited mobility in the arm
|
0.60%
1/167 • Number of events 1 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/160 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
0.00%
0/157 • AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167. Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place