Trial Outcomes & Findings for ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction (NCT NCT01559311)
NCT ID: NCT01559311
Last Updated: 2019-02-04
Results Overview
Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
12 months
Results posted on
2019-02-04
Participant Flow
The enrollment target was 177 patients. There were 8 centers from Asia Pacific and 1 center from Italy in the study. From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study. Sample size was not reached due to difficulty in enrollment.
Participant milestones
| Measure |
CRT-P OFF
Echo-guided Group - Dual chamber pacemaker (DDDR) Standard Therapy
|
CRT-P ON
Echo-guided Group - Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
|
DDDR
Control Group - DDDR Standard Therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
34
|
34
|
|
Overall Study
Implant
|
28
|
34
|
32
|
|
Overall Study
1-Month
|
27
|
34
|
29
|
|
Overall Study
3-Month
|
27
|
34
|
29
|
|
Overall Study
6-Month
|
27
|
33
|
28
|
|
Overall Study
COMPLETED
|
27
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
8
|
Reasons for withdrawal
| Measure |
CRT-P OFF
Echo-guided Group - Dual chamber pacemaker (DDDR) Standard Therapy
|
CRT-P ON
Echo-guided Group - Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
|
DDDR
Control Group - DDDR Standard Therapy
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Difficulty in cannulating the lateral ve
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
The population for this measure differs from overall number of baseline participants because of missing data
Baseline characteristics by cohort
| Measure |
CRT-P OFF
n=30 Participants
Echo-guided Group - DDDR Standard Therapy
|
CRT-P ON
n=34 Participants
Echo-guided Group - CRT-P Standard Therapy
|
DDDR
n=34 Participants
Control Group - DDDR Standard Therapy
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.53 years
STANDARD_DEVIATION 11.99 • n=30 Participants
|
68.41 years
STANDARD_DEVIATION 13.22 • n=34 Participants
|
72.29 years
STANDARD_DEVIATION 9.84 • n=34 Participants
|
69.49 years
STANDARD_DEVIATION 11.82 • n=98 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=30 Participants
|
14 Participants
n=34 Participants
|
12 Participants
n=34 Participants
|
36 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=30 Participants
|
20 Participants
n=34 Participants
|
22 Participants
n=34 Participants
|
62 Participants
n=98 Participants
|
|
Atrial Fibrillation History
None
|
30 participants
n=30 Participants
|
32 participants
n=34 Participants
|
33 participants
n=34 Participants
|
95 participants
n=98 Participants
|
|
Atrial Fibrillation History
Paroxysmal
|
0 participants
n=30 Participants
|
2 participants
n=34 Participants
|
1 participants
n=34 Participants
|
3 participants
n=98 Participants
|
|
Heart Rate
|
47.37 bpm
STANDARD_DEVIATION 16.55 • n=30 Participants
|
47.68 bpm
STANDARD_DEVIATION 10.35 • n=34 Participants
|
49 bpm
STANDARD_DEVIATION 14.64 • n=34 Participants
|
48.04 bpm
STANDARD_DEVIATION 13.85 • n=98 Participants
|
|
Rhythm on 12-lead ECG
Sinus
|
7 participants
n=30 Participants
|
11 participants
n=34 Participants
|
10 participants
n=34 Participants
|
28 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Atrial Fibrillation
|
0 participants
n=30 Participants
|
0 participants
n=34 Participants
|
1 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
2:1 Heart Block
|
5 participants
n=30 Participants
|
4 participants
n=34 Participants
|
6 participants
n=34 Participants
|
15 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
2nd Degree Heart Block
|
3 participants
n=30 Participants
|
2 participants
n=34 Participants
|
1 participants
n=34 Participants
|
6 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Complete Heart Block
|
11 participants
n=30 Participants
|
14 participants
n=34 Participants
|
12 participants
n=34 Participants
|
37 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Atrioventricular Dissociation (AVD)
|
0 participants
n=30 Participants
|
0 participants
n=34 Participants
|
1 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Intermitent Pacing
|
0 participants
n=30 Participants
|
0 participants
n=34 Participants
|
1 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Complete Heart Block with Escape Rhythm
|
1 participants
n=30 Participants
|
0 participants
n=34 Participants
|
0 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Complete AV block with junctional escape
|
0 participants
n=30 Participants
|
1 participants
n=34 Participants
|
0 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Ventricular Paced rhythm
|
0 participants
n=30 Participants
|
1 participants
n=34 Participants
|
0 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Sinus Bradycardia
|
1 participants
n=30 Participants
|
0 participants
n=34 Participants
|
1 participants
n=34 Participants
|
2 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Wenkebach
|
2 participants
n=30 Participants
|
0 participants
n=34 Participants
|
1 participants
n=34 Participants
|
3 participants
n=98 Participants
|
|
Rhythm on 12-lead ECG
Heart Block
|
0 participants
n=30 Participants
|
1 participants
n=34 Participants
|
0 participants
n=34 Participants
|
1 participants
n=98 Participants
|
|
PR interval
|
227.60 ms
STANDARD_DEVIATION 78.50 • n=15 Participants • The population for this measure differs from overall number of baseline participants because of missing data
|
236.27 ms
STANDARD_DEVIATION 80.99 • n=22 Participants • The population for this measure differs from overall number of baseline participants because of missing data
|
214.76 ms
STANDARD_DEVIATION 56.42 • n=17 Participants • The population for this measure differs from overall number of baseline participants because of missing data
|
227.09 ms
STANDARD_DEVIATION 72.60 • n=54 Participants • The population for this measure differs from overall number of baseline participants because of missing data
|
|
QRS interval
|
114.67 ms
STANDARD_DEVIATION 29.83 • n=30 Participants
|
118.82 ms
STANDARD_DEVIATION 40.06 • n=34 Participants
|
131.47 ms
STANDARD_DEVIATION 36.56 • n=34 Participants
|
121.94 ms
STANDARD_DEVIATION 36.31 • n=98 Participants
|
|
Baseline Left Ventricular Ejection Fraction (LVEF)
|
65.19 %
STANDARD_DEVIATION 8.42 • n=30 Participants
|
63.14 %
STANDARD_DEVIATION 8.70 • n=34 Participants
|
64.72 %
STANDARD_DEVIATION 7.51 • n=34 Participants
|
64.31 %
STANDARD_DEVIATION 8.18 • n=98 Participants
|
|
Baseline Left Ventricular End Systolic Volume (LVESV)
|
32.93 ml
STANDARD_DEVIATION 15.92 • n=30 Participants
|
41.55 ml
STANDARD_DEVIATION 20.22 • n=34 Participants
|
36.92 ml
STANDARD_DEVIATION 23.85 • n=34 Participants
|
37.31 ml
STANDARD_DEVIATION 20.51 • n=98 Participants
|
|
Baseline Left Ventricular End Diastolic Volume (LVEDV)
|
84.72 ml
STANDARD_DEVIATION 31.14 • n=30 Participants
|
104.28 ml
STANDARD_DEVIATION 34.08 • n=34 Participants
|
88.78 ml
STANDARD_DEVIATION 35.27 • n=34 Participants
|
92.91 ml
STANDARD_DEVIATION 34.36 • n=98 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.
Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function
Outcome measures
| Measure |
CRT-P OFF
n=27 Participants
Echo-guided Group - DDDR Standard Therapy
|
CRT-P ON
n=28 Participants
Echo-guided Group - CRT-P Standard Therapy
|
DDDR
n=26 Participants
Control Group - DDDR Standard Therapy
|
|---|---|---|---|
|
LVEF
|
64.22 % LVEF
Standard Deviation 7.53
|
63.14 % LVEF
Standard Deviation 7.51
|
59.96 % LVEF
Standard Deviation 10.47
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.
Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling
Outcome measures
| Measure |
CRT-P OFF
n=27 Participants
Echo-guided Group - DDDR Standard Therapy
|
CRT-P ON
n=28 Participants
Echo-guided Group - CRT-P Standard Therapy
|
DDDR
n=26 Participants
Control Group - DDDR Standard Therapy
|
|---|---|---|---|
|
LVESV
|
30.52 ml
Standard Deviation 14.73
|
34.54 ml
Standard Deviation 14.74
|
36.38 ml
Standard Deviation 21.73
|
Adverse Events
CRT-P OFF
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
CRT-P ON
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
DDDR
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRT-P OFF
n=30 participants at risk
Echo-guided Group - DDDR Standard Therapy
|
CRT-P ON
n=34 participants at risk
Echo-guided Group - CRT-P Standard Therapy
|
DDDR
n=34 participants at risk
Control Group - DDDR Standard Therapy
|
|---|---|---|---|
|
General disorders
Acute renal failure
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Angina
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Atypical chest pain
|
3.3%
1/30 • Number of events 6 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Coronary Artery Disease (CAD)
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
8.8%
3/34 • Number of events 3 • 12 Months Follow Up
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Cardiac disorders
Carotid stenosis
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Chest wall pain
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Death
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Dehydration
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Diaphragmatic/ phrenic stimulation
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Dizziness
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Extrusion
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Hepatobiliary disorders
Fatty liver
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Fluid retention
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Gout
|
3.3%
1/30 • Number of events 2 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Heart failure
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Hematoma
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Renal and urinary disorders
Hypervolemia
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 2 • 12 Months Follow Up
|
|
Infections and infestations
Infected osteoradionecrosis
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Inguinal hernia
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Knee effusion
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Lead dislodgement
|
0.00%
0/30 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 2 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 2 • 12 Months Follow Up
|
|
General disorders
Lead repositioning
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Cardiac disorders
Non ST-segment elevation myocardial infarction (NSTEMI)
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 2 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 2 • 12 Months Follow Up
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Renal and urinary disorders
Renal imairment
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Sepsis
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Supraglottitis
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Wound pain
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
Other adverse events
| Measure |
CRT-P OFF
n=30 participants at risk
Echo-guided Group - DDDR Standard Therapy
|
CRT-P ON
n=34 participants at risk
Echo-guided Group - CRT-P Standard Therapy
|
DDDR
n=34 participants at risk
Control Group - DDDR Standard Therapy
|
|---|---|---|---|
|
Hepatobiliary disorders
Abnormal liver function tests (LFTs)
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Accidental injury
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
8.8%
3/34 • Number of events 3 • 12 Months Follow Up
|
|
Eye disorders
Cataract
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Cardiac disorders
Coronary sinus dissection
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Cardiac disorders
Decreased LVEF
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Eye disorders
Degenerative myopia
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Dehydration
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Dehydration
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Endocrine disorders
Diabetes mellitus
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Diaphragmatic/ phrenic stimulation
|
0.00%
0/30 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 3 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Cardiac disorders
Edema
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Elbow and shoulder pain
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Reproductive system and breast disorders
Enlarged prostate
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Epistaxis
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Infections and infestations
Eye infection
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Eye disorders
Eye itching
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Frozen sholder
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Respiratory, thoracic and mediastinal disorders
Globus sensation
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Endocrine disorders
Glucosuria
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 2 • 12 Months Follow Up
|
|
General disorders
Hematoma
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
8.8%
3/34 • Number of events 3 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Gastrointestinal disorders
Hemorrhoid
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Hyperkalemia
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Cardiac disorders
Hypertension
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Cardiac disorders
Hypotension
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Infection
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Lead dislodgement
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Lead fixation difficulty
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Medication induced side effects
|
3.3%
1/30 • Number of events 2 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Metabolic acidosis
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Mode switch
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Otitis
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Gastrointestinal disorders
Peri-rectal bleeding
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Pericardial effusion
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Pleural effusion
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Musculoskeletal and connective tissue disorders
Shoulder dislocation
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Suspected cancer
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Syncope
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
General disorders
Threshold increase
|
0.00%
0/30 • 12 Months Follow Up
|
8.8%
3/34 • Number of events 3 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
|
Infections and infestations
Tuberculosis
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 2 • 12 Months Follow Up
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
5.9%
2/34 • Number of events 2 • 12 Months Follow Up
|
|
Infections and infestations
Varicella Zoster
|
3.3%
1/30 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
Infections and infestations
Wound infection
|
0.00%
0/30 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
|
General disorders
Muscle cramps
|
0.00%
0/30 • 12 Months Follow Up
|
0.00%
0/34 • 12 Months Follow Up
|
2.9%
1/34 • Number of events 1 • 12 Months Follow Up
|
Additional Information
Clinical Project Leader Asia
St. Jude Medical (Hong Kong) Ltd
Phone: 29967605
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60