Trial Outcomes & Findings for Attain Performa(TM) Quadripolar Lead Study (NCT NCT01751022)
NCT ID: NCT01751022
Last Updated: 2016-12-05
Results Overview
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: \- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%). \- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months. The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1202 participants
Primary outcome timeframe
Implant to 6 months post-implant
Results posted on
2016-12-05
Participant Flow
Out of the 1202 Intial enrollments; 77 were excluded due to to the following pre-implant events: 1. unsuccessful cannulation (25) 2. death (3) 3. Exit prior to implant attempt (43) 4. Attain Performa Lead implant not attempted (6) Resulting in 1125 subjects with Attain Performa Lead Implant Attempts
Participant milestones
| Measure |
Model 4298
Patients with an implant attempt for the Attain Performa Lead Model 4298
|
Model 4398
Patients with an implant attempt for the Attain Performa Lead Model 4398
|
Model 4598
Patients with an implant attempt for the Attain Performa Lead Model 4598
|
|---|---|---|---|
|
Overall Study
STARTED
|
499
|
326
|
300
|
|
Overall Study
COMPLETED
|
443
|
282
|
273
|
|
Overall Study
NOT COMPLETED
|
56
|
44
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attain Performa(TM) Quadripolar Lead Study
Baseline characteristics by cohort
| Measure |
Attain Performa LV Lead Model 4298
n=499 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant
|
Attain Performa LV Lead Model 4398
n=326 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant
|
Attain Performa LV Lead Model 4598
n=300 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant
|
Total
n=1125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
Chile
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 11 • n=5 Participants
|
66 years
STANDARD_DEVIATION 11 • n=7 Participants
|
67 years
STANDARD_DEVIATION 11 • n=5 Participants
|
67 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
329 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
796 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Subject/physician chose not to provide information
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not reportable per local laws or regulations
|
30 participants
n=5 Participants
|
21 participants
n=7 Participants
|
48 participants
n=5 Participants
|
99 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
38 participants
n=5 Participants
|
21 participants
n=7 Participants
|
17 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
387 participants
n=5 Participants
|
252 participants
n=7 Participants
|
197 participants
n=5 Participants
|
836 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Two or more races
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
360 participants
n=5 Participants
|
249 participants
n=7 Participants
|
152 participants
n=5 Participants
|
761 participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Saudi Arabia
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
8 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Slovenia
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
11 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
India
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
15 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Norway
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
17 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
19 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
New York Heart Association Classification (NYHA)
I
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
New York Heart Association Classification (NYHA)
II
|
125 participants
n=5 Participants
|
94 participants
n=7 Participants
|
89 participants
n=5 Participants
|
308 participants
n=4 Participants
|
|
New York Heart Association Classification (NYHA)
III
|
352 participants
n=5 Participants
|
216 participants
n=7 Participants
|
198 participants
n=5 Participants
|
766 participants
n=4 Participants
|
|
New York Heart Association Classification (NYHA)
IV
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
9 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
25 %
STANDARD_DEVIATION 7 • n=5 Participants
|
26 %
STANDARD_DEVIATION 7 • n=7 Participants
|
27 %
STANDARD_DEVIATION 7 • n=5 Participants
|
26 %
STANDARD_DEVIATION 7 • n=4 Participants
|
|
QRS (Electrocardiogram Complex)
|
155 ms
STANDARD_DEVIATION 23 • n=5 Participants
|
156 ms
STANDARD_DEVIATION 24 • n=7 Participants
|
156 ms
STANDARD_DEVIATION 23 • n=5 Participants
|
156 ms
STANDARD_DEVIATION 23 • n=4 Participants
|
PRIMARY outcome
Timeframe: Implant to 6 months post-implantPopulation: Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: \- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%). \- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months. The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=499 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=326 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=300 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Lead Complication-free Rate at 6 Months
|
96.04 Survival Probability (%)
Interval 94.3 to 100.0
|
98.75 Survival Probability (%)
Interval 97.55 to 100.0
|
96.21 Survival Probability (%)
Interval 94.04 to 100.0
|
PRIMARY outcome
Timeframe: 6 months post-implantPopulation: Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=395 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=266 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=266 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
LV Pacing Capture Thresholds Per Attain Performa Lead Model
|
93.92 percentage of participants
Interval 91.09 to 100.0
|
96.24 percentage of participants
Interval 93.2 to 100.0
|
95.86 percentage of participants
Interval 92.72 to 100.0
|
SECONDARY outcome
Timeframe: 6 months post-implantPopulation: Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.
Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=395 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=267 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=267 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV1-RV COIL
|
42.03 percentage of participants
|
44.19 percentage of participants
|
44.57 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV1-LV2
|
38.48 percentage of participants
|
40.45 percentage of participants
|
35.58 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV1-LV3
|
38.99 percentage of participants
|
40.45 percentage of participants
|
35.58 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV1-LV4
|
34.18 percentage of participants
|
34.83 percentage of participants
|
37.83 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV2-RV COIL
|
33.92 percentage of participants
|
33.71 percentage of participants
|
27.72 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV2 -LV1
|
34.94 percentage of participants
|
32.21 percentage of participants
|
27.34 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV2-LV3
|
12.66 percentage of participants
|
18.35 percentage of participants
|
10.86 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV2-LV4
|
27.85 percentage of participants
|
25.47 percentage of participants
|
22.47 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV3-RV COIL
|
31.39 percentage of participants
|
31.84 percentage of participants
|
24.72 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV3-LV1
|
33.42 percentage of participants
|
31.46 percentage of participants
|
31.84 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV3-LV2
|
12.91 percentage of participants
|
15.36 percentage of participants
|
8.61 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV3-LV4
|
26.58 percentage of participants
|
23.60 percentage of participants
|
18.73 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV4-RV COIL
|
21.52 percentage of participants
|
17.98 percentage of participants
|
19.10 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV4-LV1
|
26.58 percentage of participants
|
24.34 percentage of participants
|
24.72 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV4-LV2
|
21.27 percentage of participants
|
20.22 percentage of participants
|
17.60 percentage of participants
|
|
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
LV4-LV3
|
20.76 percentage of participants
|
19.10 percentage of participants
|
16.10 percentage of participants
|
SECONDARY outcome
Timeframe: Implant up to 1-month post implantPopulation: Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=499 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=326 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=300 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
|
97.60 percentage of participants
Interval 95.84 to 98.75
|
97.55 percentage of participants
Interval 95.22 to 98.93
|
98.00 percentage of participants
Interval 95.7 to 99.26
|
SECONDARY outcome
Timeframe: Implant up to 1-month post implantPopulation: Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=499 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=326 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=300 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Acceptable
|
98.00 percentage of participants
|
98.47 percentage of participants
|
98.67 percentage of participants
|
|
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Unacceptable
|
0.20 percentage of participants
|
0.31 percentage of participants
|
0.33 percentage of participants
|
|
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
No Response
|
1.80 percentage of participants
|
1.23 percentage of participants
|
1.00 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months post-implantPopulation: Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=395 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=266 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=266 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Pacing Capture Thresholds at the Final Programmed Pacing Polarity
|
1.06 Volts
Standard Deviation 0.74
|
1.15 Volts
Standard Deviation 0.76
|
1.10 Volts
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Implant up to 1-month post implantPopulation: Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=487 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=318 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=294 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Implant Related Times Per Attain Performa Lead Model
Fluoroscopy
|
21.7 minutes
Standard Deviation 15.4
|
23.00 minutes
Standard Deviation 17.29
|
18.77 minutes
Standard Deviation 12.66
|
|
Implant Related Times Per Attain Performa Lead Model
Cannulation
|
6.3 minutes
Standard Deviation 9.5
|
8.45 minutes
Standard Deviation 14.47
|
6.87 minutes
Standard Deviation 11.19
|
|
Implant Related Times Per Attain Performa Lead Model
LV Lead Placement
|
13.0 minutes
Standard Deviation 15.9
|
17.26 minutes
Standard Deviation 26.21
|
11.82 minutes
Standard Deviation 14.17
|
|
Implant Related Times Per Attain Performa Lead Model
Total Operation
|
109.6 minutes
Standard Deviation 49.0
|
107.96 minutes
Standard Deviation 53.46
|
95.09 minutes
Standard Deviation 43.38
|
SECONDARY outcome
Timeframe: 6 month post-implantPopulation: Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.
Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1. Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=395 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=266 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=267 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV1 to RV Coil
|
460.56 Ohms
Standard Deviation 124.26
|
466.24 Ohms
Standard Deviation 123.63
|
496.45 Ohms
Standard Deviation 133.92
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV1 to LV2
|
780.49 Ohms
Standard Deviation 228.00
|
802.52 Ohms
Standard Deviation 240.30
|
826.69 Ohms
Standard Deviation 275.82
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV1 to LV3
|
776.64 Ohms
Standard Deviation 192.41
|
792.62 Ohms
Standard Deviation 195.78
|
826.15 Ohms
Standard Deviation 278.05
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV1 to LV4
|
750.14 Ohms
Standard Deviation 171.98
|
761.79 Ohms
Standard Deviation 175.08
|
799.70 Ohms
Standard Deviation 225.09
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV2 to RV Coil
|
462.63 Ohms
Standard Deviation 168.82
|
476.71 Ohms
Standard Deviation 193.46
|
483.99 Ohms
Standard Deviation 247.31
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV2 to LV3
|
562.40 Ohms
Standard Deviation 179.24
|
568.36 Ohms
Standard Deviation 197.87
|
580.02 Ohms
Standard Deviation 247.99
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV2 to LV4
|
730.26 Ohms
Standard Deviation 196.11
|
755.85 Ohms
Standard Deviation 214.04
|
756.48 Ohms
Standard Deviation 257.78
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV3 to RV Coil
|
450.29 Ohms
Standard Deviation 107.29
|
458.86 Ohms
Standard Deviation 110.62
|
468.90 Ohms
Standard Deviation 247.12
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV3 to LV4
|
715.20 Ohms
Standard Deviation 159.58
|
733.30 Ohms
Standard Deviation 164.21
|
740.99 Ohms
Standard Deviation 254.57
|
|
Pacing Impedance at the Final Programmed Pacing Polarity
LV4 to RV Coil
|
406.24 Ohms
Standard Deviation 87.12
|
407.17 Ohms
Standard Deviation 87.09
|
421.69 Ohms
Standard Deviation 180.51
|
SECONDARY outcome
Timeframe: 6 month post-ImplantPopulation: Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.
Outcome measures
| Measure |
Attain Performa LV Lead Model 4298
n=487 Participants
Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
|
Attain Performa LV Lead Model 4398
n=318 Participants
Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
|
Attain Performa LV Lead Model 4598
n=294 Participants
Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
|
|---|---|---|---|
|
Complication Rate for Individual Attain Performa Lead Related Events
|
3.70 percentage of participants
Interval 2.2 to 5.78
|
1.58 percentage of participants
Interval 0.51 to 3.64
|
3.74 percentage of participants
Interval 1.88 to 6.6
|
Adverse Events
Attain Performa LV Lead Model 4298
Serious events: 218 serious events
Other events: 155 other events
Deaths: 0 deaths
Attain Performa LV Lead Model 4398
Serious events: 134 serious events
Other events: 84 other events
Deaths: 0 deaths
Attain Performa LV Lead Model 4598
Serious events: 117 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Attain Performa LV Lead Model 4298
n=499 participants at risk
Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
|
Attain Performa LV Lead Model 4398
n=326 participants at risk
Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
|
Attain Performa LV Lead Model 4598
n=300 participants at risk
Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
5/499 • Number of events 5
|
0.31%
1/326 • Number of events 1
|
0.67%
2/300 • Number of events 2
|
|
Cardiac disorders
AFib
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Acute heart failure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Alcoholic cardiomyopathy
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Cardiac disorders
Aortic regurgitation
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Aortic valve stenosis
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 2
|
|
Cardiac disorders
Asystole
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Atrial arrhythmia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
16/499 • Number of events 18
|
3.7%
12/326 • Number of events 16
|
1.0%
3/300 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation paroxysmal
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.80%
4/499 • Number of events 4
|
0.31%
1/326 • Number of events 1
|
1.0%
3/300 • Number of events 3
|
|
Cardiac disorders
Atrial flutter
|
0.80%
4/499 • Number of events 5
|
1.5%
5/326 • Number of events 7
|
0.67%
2/300 • Number of events 2
|
|
Cardiac disorders
Atrial tachycardia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Atypical angina
|
0.40%
2/499 • Number of events 2
|
0.61%
2/326 • Number of events 9
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/499
|
1.2%
4/326 • Number of events 4
|
0.00%
0/300
|
|
Cardiac disorders
Cardiac arrhythmia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.67%
2/300 • Number of events 2
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/499
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Cardiovascular disease, unspecified
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Chronic heart failure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Congestive heart failure
|
0.20%
1/499 • Number of events 1
|
1.2%
4/326 • Number of events 4
|
0.67%
2/300 • Number of events 2
|
|
Cardiac disorders
Coronary artery disease
|
0.40%
2/499 • Number of events 3
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Decompensated heart failure
|
11.4%
57/499 • Number of events 84
|
9.2%
30/326 • Number of events 51
|
11.0%
33/300 • Number of events 46
|
|
Cardiac disorders
Electromechanical dissociation
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Heart fluttering
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Intracardiac mass
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Mitral valve disease
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Monomorphic ventricular tachycardia
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 3
|
1.0%
3/300 • Number of events 3
|
|
Cardiac disorders
Non-ischemic cardiomyopathy
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.00%
0/499
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Cardiac disorders
Pericardial effusion
|
0.40%
2/499 • Number of events 2
|
0.92%
3/326 • Number of events 4
|
0.00%
0/300
|
|
Cardiac disorders
Pericarditis
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Permanent atrial fibrillation
|
0.00%
0/499
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Cardiac disorders
Persistent atrial fibrillation
|
0.60%
3/499 • Number of events 3
|
0.61%
2/326 • Number of events 2
|
1.3%
4/300 • Number of events 4
|
|
Cardiac disorders
Premature ventricular contractions
|
0.60%
3/499 • Number of events 3
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Recurrent atrial fibrillation
|
0.00%
0/499
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/499
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Sustained ventricular tachycardia
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Tachycardia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Torsades de pointes
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Tricuspid valve disease
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Unstable angina
|
0.60%
3/499 • Number of events 3
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Ventricular ectopic beats
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Ventricular fibrillation
|
0.60%
3/499 • Number of events 3
|
0.00%
0/326
|
1.0%
3/300 • Number of events 3
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Ventricular tachycardia
|
0.80%
4/499 • Number of events 4
|
0.31%
1/326 • Number of events 1
|
2.3%
7/300 • Number of events 8
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Ear and labyrinth disorders
Benign paroxysmal positional vertigo
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Eye disorders
Right cataract
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Abdominal catastrophe
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
2/499 • Number of events 3
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Gastrointestinal disorders
Acute duodenal ulcer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Antral ulcer
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Gastrointestinal disorders
Barrett s esophagus
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Diarrhea
|
0.20%
1/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
GI bleed
|
1.4%
7/499 • Number of events 9
|
0.61%
2/326 • Number of events 2
|
0.67%
2/300 • Number of events 2
|
|
Gastrointestinal disorders
GI upset
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Gastro intestinal bleed
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Gastrocutaneous fistula
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Gastrointestinal disorders
Hernia hiatal
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Oesophageal reflux
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Gastrointestinal disorders
Parotid cyst
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Ruptured diverticulum
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Adverse drug reaction
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Chest Pain
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Chest pain
|
2.0%
10/499 • Number of events 10
|
2.1%
7/326 • Number of events 24
|
1.0%
3/300 • Number of events 3
|
|
General disorders
Chest tightness
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Chronic chest pain
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Coronary restenosis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Device capturing issue
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Device connection issue
|
0.60%
3/499 • Number of events 3
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Device malfunction
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Drug side effect
|
0.00%
0/499
|
0.92%
3/326 • Number of events 3
|
0.00%
0/300
|
|
General disorders
Elevated pacing threshold
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Fever
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Hypothermia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Implant site edema
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Implant site erythema
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Implant site hematoma
|
0.40%
2/499 • Number of events 2
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Implant site pain
|
0.60%
3/499 • Number of events 3
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Inappropriate phrenic nerve stimulation
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 2
|
0.00%
0/300
|
|
General disorders
Inappropriate stimulation of diaphragm
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Injection site reaction
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Lead dislodgement
|
3.2%
16/499 • Number of events 17
|
0.92%
3/326 • Number of events 4
|
2.7%
8/300 • Number of events 8
|
|
General disorders
Loss of capture
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Multi organ failure
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.40%
2/499 • Number of events 2
|
0.61%
2/326 • Number of events 4
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Pain
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Phantom shocks
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Premature battery depletion
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Substernal chest pain
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Sudden death
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Undersensing
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Unknown cause of death
|
0.80%
4/499 • Number of events 4
|
0.31%
1/326 • Number of events 1
|
1.3%
4/300 • Number of events 4
|
|
General disorders
Weakness
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Hepatobiliary disorders
Chronic cholecystitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Acute bronchitis
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Acute gastroenteritis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Acute tracheobronchitis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Appendicitis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Bacteremia
|
0.60%
3/499 • Number of events 4
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Bronchitis
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Bronchitis viral
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
C.difficile colitis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Cellulitis of leg
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Cellulitis of toe
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Endocarditis
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Implant site infection
|
1.0%
5/499 • Number of events 5
|
0.61%
2/326 • Number of events 2
|
0.67%
2/300 • Number of events 2
|
|
Infections and infestations
Infection of amputation stump
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/499
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Infections and infestations
Peritonitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Pneumonia
|
1.4%
7/499 • Number of events 8
|
2.5%
8/326 • Number of events 9
|
3.0%
9/300 • Number of events 12
|
|
Infections and infestations
Prosthesis related infection
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Pulmonary sepsis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Renal abscess
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.0%
5/499 • Number of events 5
|
0.61%
2/326 • Number of events 3
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Sepsis MRSA
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/499
|
0.00%
0/326
|
0.67%
2/300 • Number of events 3
|
|
Infections and infestations
Septic joint
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Septic shock
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Sigmoid diverticulitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Staphylococcal infection
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Staphylococcus aureus septicemia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Streptococcus viridans group infection
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.0%
5/499 • Number of events 6
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.40%
2/499 • Number of events 2
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Contusion of hip
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Digoxin toxicity
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
False aneurysm
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Foreign body in esophagus
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Fracture
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Fractured cervical spine
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative bleeding
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Medication error
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Postoperative bleeding
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Spurious aneurysm
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Subdural hemorrhage
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Therapeutic procedural complication
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Injury, poisoning and procedural complications
Trochanteric femoral fracture
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Injury, poisoning and procedural complications
Twiddler s syndrome
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.20%
1/499 • Number of events 2
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Investigations
Abnormal coagulation profile
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Investigations
Elevated liver enzymes
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Investigations
Subtherapeutic INR
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Gout
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.60%
3/499 • Number of events 4
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
5/499 • Number of events 5
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Volume depletion
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Metabolism and nutrition disorders
Volume overload
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical disc herniation
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis knee
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma lung
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowel cancer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma progression
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic adenocarcinoma
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate adenoma
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
CVA
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Cerebral infarct
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Nervous system disorders
Convulsive seizure
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Nervous system disorders
Dizziness
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.20%
1/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Intracerebral hemorrhage
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Nervous system disorders
Ischemic stroke
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Lethargy
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Nervous system disorders
Lightheadedness
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Myelitis transverse
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Stroke
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Syncope
|
1.2%
6/499 • Number of events 6
|
0.61%
2/326 • Number of events 2
|
1.0%
3/300 • Number of events 3
|
|
Nervous system disorders
Transient ischemic attacks
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Psychiatric disorders
Acute delirium
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 3
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Acute on chronic renal failure
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Acute renal failure
|
1.0%
5/499 • Number of events 6
|
0.61%
2/326 • Number of events 2
|
1.0%
3/300 • Number of events 6
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.67%
2/300 • Number of events 2
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.40%
2/499 • Number of events 2
|
0.61%
2/326 • Number of events 3
|
0.00%
0/300
|
|
Renal and urinary disorders
Chronic renal insufficiency
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Renal and urinary disorders
Hematuria
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Renal and urinary disorders
Injury to kidney
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Renal and urinary disorders
Kidney failure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Renal and urinary disorders
Renal failure
|
1.0%
5/499 • Number of events 5
|
0.31%
1/326 • Number of events 1
|
0.67%
2/300 • Number of events 2
|
|
Renal and urinary disorders
Renal insufficiency
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.67%
2/300 • Number of events 2
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Retention urinary
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
3/499 • Number of events 3
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/499
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.20%
1/499 • Number of events 5
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/499
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Flash pulmonary edema
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic respiratory failure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial pulmonary fibrosis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.60%
3/499 • Number of events 4
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
5/499 • Number of events 6
|
0.92%
3/326 • Number of events 3
|
1.3%
4/300 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.80%
4/499 • Number of events 4
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Skin and subcutaneous tissue disorders
Diabetic foot ulcer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Skin and subcutaneous tissue disorders
Foot ulcer
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Surgical and medical procedures
AV fistula excision
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Surgical and medical procedures
Enterostomy closure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Aneurysm
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Arterial bleeding
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Claudication
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 3
|
|
Vascular disorders
DVT
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
2/499 • Number of events 2
|
0.92%
3/326 • Number of events 3
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Hypertension
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Hypertension worsened
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Hypertensive episode
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Hypotension
|
0.80%
4/499 • Number of events 6
|
0.61%
2/326 • Number of events 2
|
1.7%
5/300 • Number of events 5
|
|
Vascular disorders
Ischemia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Leg ischemia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Obstructive arteriosclerosis of lower extremities
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.67%
2/300 • Number of events 2
|
|
Vascular disorders
Peripheral arterial disease
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disease
|
0.00%
0/499
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/499
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
Vascular disorders
Uncontrolled hypertension
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
Other adverse events
| Measure |
Attain Performa LV Lead Model 4298
n=499 participants at risk
Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
|
Attain Performa LV Lead Model 4398
n=326 participants at risk
Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
|
Attain Performa LV Lead Model 4598
n=300 participants at risk
Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
AFib
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
12/499 • Number of events 13
|
0.92%
3/326 • Number of events 3
|
4.0%
12/300 • Number of events 13
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Atrial flutter
|
0.40%
2/499 • Number of events 3
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Cardiac disorders
Atrial tachycardia
|
0.60%
3/499 • Number of events 3
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Atypical angina
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Cardiac disorders
Decompensated heart failure
|
6.2%
31/499 • Number of events 35
|
5.5%
18/326 • Number of events 18
|
4.7%
14/300 • Number of events 17
|
|
Cardiac disorders
Junctional rhythm
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
LV dyssynchrony
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Monomorphic ventricular tachycardia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.80%
4/499 • Number of events 4
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
1.0%
3/300 • Number of events 3
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Paroxysmal ventricular tachycardia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Persistent atrial fibrillation
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Premature beat atrial
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Premature ventricular contractions
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Cardiac disorders
Recurrent ventricular tachycardia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Cardiac disorders
Sinus tachycardia
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.80%
4/499 • Number of events 4
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Sustained ventricular tachycardia
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.40%
2/499 • Number of events 4
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
1.6%
8/499 • Number of events 9
|
0.61%
2/326 • Number of events 2
|
1.0%
3/300 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Adverse drug reaction
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Chest pain
|
1.6%
8/499 • Number of events 11
|
0.92%
3/326 • Number of events 3
|
1.3%
4/300 • Number of events 4
|
|
General disorders
Chest pressure
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Device alarm issue
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Device connection issue
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Device damage
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Device electrical impedance issue
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Device migration
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Device stimulation issue
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Edema extremities
|
0.40%
2/499 • Number of events 3
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Elevated pacing threshold
|
0.40%
2/499 • Number of events 2
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Failure to capture
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Fatigue
|
0.60%
3/499 • Number of events 3
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Impedance increased
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Implant site bleeding
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Implant site bruising
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Implant site burning
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Implant site edema
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Implant site erythema
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Implant site hematoma
|
2.2%
11/499 • Number of events 12
|
1.5%
5/326 • Number of events 5
|
0.00%
0/300
|
|
General disorders
Implant site irritation
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Implant site numbness
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Implant site pain
|
1.4%
7/499 • Number of events 10
|
1.2%
4/326 • Number of events 6
|
1.7%
5/300 • Number of events 5
|
|
General disorders
Inappropriate device stimulation of tissue
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Inappropriate phrenic nerve stimulation
|
3.6%
18/499 • Number of events 20
|
7.1%
23/326 • Number of events 27
|
6.0%
18/300 • Number of events 19
|
|
General disorders
Inappropriate stimulation of diaphragm
|
4.2%
21/499 • Number of events 23
|
4.0%
13/326 • Number of events 14
|
2.7%
8/300 • Number of events 8
|
|
General disorders
Lead dislodgement
|
0.80%
4/499 • Number of events 4
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Lead impedance abnormally low
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Lead microdislodgement
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Loss of capture
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Oversensing
|
0.80%
4/499 • Number of events 4
|
0.00%
0/326
|
0.67%
2/300 • Number of events 2
|
|
General disorders
Pacing threshold increased
|
0.00%
0/499
|
0.92%
3/326 • Number of events 3
|
0.00%
0/300
|
|
General disorders
Phantom shocks
|
0.40%
2/499 • Number of events 3
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Swelling arm
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
General disorders
Tissue erosion associated with device
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
General disorders
Undersensing
|
0.60%
3/499 • Number of events 3
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Weakness worsened
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
General disorders
Wound healing delayed
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Cellulitis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Infections and infestations
Cystitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Implant site cellulitis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Infections and infestations
Implant site infection
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
1.0%
3/300 • Number of events 3
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Cardiac vein dissection
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion of chest wall
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Coronary sinus dissection
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
1.0%
3/300 • Number of events 3
|
|
Injury, poisoning and procedural complications
Coronary sinus perforation
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Opiate toxicity
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Injury, poisoning and procedural complications
Scalp laceration
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Investigations
Oxygen saturation low
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Investigations
Raised blood pressure
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Investigations
Troponin increased
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hypervolemia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Metabolism and nutrition disorders
Volume overload
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Musculoskeletal and connective tissue disorders
Pain in arm
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Nervous system disorders
Carotid artery occlusion
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Dizziness
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Near syncope
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Paresthesia
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Pre-syncope
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Nervous system disorders
Syncope
|
0.20%
1/499 • Number of events 2
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Nervous system disorders
Thrombotic stroke
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Nervous system disorders
Vasovagal reaction
|
0.20%
1/499 • Number of events 1
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.40%
2/499 • Number of events 2
|
0.00%
0/326
|
0.00%
0/300
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cheyne-Stokes respiration
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Exertional dyspnea
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Paroxysmal nocturnal dyspnea
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.60%
3/499 • Number of events 3
|
0.31%
1/326 • Number of events 1
|
0.33%
1/300 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme type skin reaction
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Skin and subcutaneous tissue disorders
Ulcus cruris
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Venous stasis ulcer
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/499
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Arterial insufficiency peripheral
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Cardiovascular collapse
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
1.0%
3/300 • Number of events 3
|
|
Vascular disorders
Hematoma
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Hypertension
|
1.2%
6/499 • Number of events 6
|
0.00%
0/326
|
1.3%
4/300 • Number of events 4
|
|
Vascular disorders
Hypertension worsened
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Hypotension
|
2.2%
11/499 • Number of events 14
|
0.61%
2/326 • Number of events 2
|
0.33%
1/300 • Number of events 1
|
|
Vascular disorders
Low BP
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Orthostatic hypotension
|
0.60%
3/499 • Number of events 3
|
0.31%
1/326 • Number of events 1
|
0.00%
0/300
|
|
Vascular disorders
Peripheral vascular disease
|
0.20%
1/499 • Number of events 1
|
0.61%
2/326 • Number of events 2
|
0.00%
0/300
|
|
Vascular disorders
Superior vena cava stenosis
|
0.20%
1/499 • Number of events 1
|
0.00%
0/326
|
0.00%
0/300
|
|
Vascular disorders
Thrombosis
|
0.00%
0/499
|
0.00%
0/326
|
0.33%
1/300 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60