Trial Outcomes & Findings for Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar (NCT NCT00810264)
NCT ID: NCT00810264
Last Updated: 2019-11-29
Results Overview
The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).
Recruitment status
COMPLETED
Target enrollment
2499 participants
Primary outcome timeframe
5 years
Results posted on
2019-11-29
Participant Flow
Participant milestones
| Measure |
BIOTRONIK Corox BP LV Lead
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
|---|---|
|
Overall Study
STARTED
|
2499
|
|
Overall Study
COMPLETED
|
946
|
|
Overall Study
NOT COMPLETED
|
1553
|
Reasons for withdrawal
| Measure |
BIOTRONIK Corox BP LV Lead
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
191
|
|
Overall Study
Withdrawal by subject or physician
|
721
|
|
Overall Study
Death
|
641
|
Baseline Characteristics
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
Baseline characteristics by cohort
| Measure |
BIOTRONIK Corox BP LV Lead
n=2498 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
724 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1774 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1805 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
244 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
220 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
117 Participants
n=5 Participants
|
|
Height
|
67.7 inches
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Weight
|
194.4 pounds
STANDARD_DEVIATION 48.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.
The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=946 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
|
94.19 percentage of subjects
Interval 92.5 to 95.59
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event.
Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=946 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Percentage of Subjects Experiencing Individual Complications
Lead dislodgement (>180 days post-implant)
|
3.28 percentage of subjects
Interval 2.24 to 4.62
|
—
|
—
|
|
Percentage of Subjects Experiencing Individual Complications
Abnormal pacing impedance
|
1.90 percentage of subjects
Interval 1.13 to 2.99
|
—
|
—
|
|
Percentage of Subjects Experiencing Individual Complications
Conductor fracture
|
0.53 percentage of subjects
Interval 0.17 to 1.23
|
—
|
—
|
|
Percentage of Subjects Experiencing Individual Complications
Malposition, excess slack
|
0.11 percentage of subjects
Interval 0.0 to 0.59
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The subjects analyzed in this outcome must have been consented, implanted with a BIOTRONIK Corox BP LV lead, and completed an in-office 5 year visit. Subjects who did not complete an in-office 5 year visit are excluded from this analysis population.
Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=611 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.
|
97.4 percentage of CRT pacing
Standard Deviation 8.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsSerious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=2499 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
LV lead cardiac perforation
|
0.04 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
LV lead high pacing threshold, no lead capture
|
0.96 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
LV lead diaphragmatic / pectoral stimulation
|
1.00 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
LV lead dislodgement (<180 days post-implant)
|
1.64 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
RV pacing lead related adverse event
|
0.16 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Device related adverse event
|
0.28 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Other adverse event
|
1.36 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
RA lead related adverse event
|
2.08 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Implant procedure related adverse event
|
3.20 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
ICD lead related adverse event
|
3.96 Percent of subjects
|
—
|
—
|
|
Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
Other high pacing threshold
|
0.04 Percent of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=2499 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Corox BP LV Lead Pacing Threshold Measurements
|
1.41 V
Standard Deviation 1.09
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsSensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=2499 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Corox BP LV Lead Sensing Measurements
|
13.94 mV
Standard Deviation 7.51
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsImpedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=2499 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Corox BP LV Lead Impedance Measurements
|
726.5 ohms
Standard Deviation 250.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=686 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
n=1129 Participants
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
n=684 Participants
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Pacing Threshold Measurements Per Corox BP LV Lead Model
|
1.30 V
Standard Deviation 1.01
|
1.40 V
Standard Deviation 1.09
|
1.53 V
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: 5 yearsSensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=686 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
n=1129 Participants
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
n=684 Participants
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Sensing Measurements Per Corox BP LV Lead Model
|
14.82 mV
Standard Deviation 7.74
|
13.94 mV
Standard Deviation 7.59
|
13.04 mV
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: 5 yearsImpedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=686 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
n=1129 Participants
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
n=684 Participants
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Impedance Measurements Per Corox BP LV Lead Model
|
730.3 ohms
Standard Deviation 264.9
|
734.4 ohms
Standard Deviation 251.7
|
709.2 ohms
Standard Deviation 233.1
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.
Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=279 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
n=401 Participants
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
n=266 Participants
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model
|
7.17 percentage of subjects
Interval 4.43 to 10.85
|
6.48 percentage of subjects
Interval 4.28 to 9.36
|
3.38 percentage of subjects
Interval 1.56 to 6.33
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group.
Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.
Outcome measures
| Measure |
BIOTRONIK Corox BP LV Lead
n=279 Participants
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
Corox OTW-S BP
n=401 Participants
Subjects consented and originally implanted with a Corox OTW-S BP lead.
|
Corox OTW-L BP
n=266 Participants
Subjects consented and originally implanted with a Corox OTW-L BP lead.
|
|---|---|---|---|
|
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Lead dislodgement (>180 days post-implant)
|
3.58 percentage of subjects
Interval 1.73 to 6.49
|
3.49 percentage of subjects
Interval 1.92 to 5.79
|
2.63 percentage of subjects
Interval 1.06 to 5.35
|
|
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Abnormal pacing impedance
|
1.79 percentage of subjects
Interval 0.58 to 4.13
|
2.99 percentage of subjects
Interval 1.56 to 5.17
|
0.38 percentage of subjects
Interval 0.01 to 2.08
|
|
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Conductor fracture
|
1.79 percentage of subjects
Interval 0.58 to 4.13
|
0 percentage of subjects
Unable to obtain confidence interval for 0 subjects
|
0 percentage of subjects
Unable to obtain confidence interval for 0 subjects
|
|
Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
Malposition, excess slack
|
0 percentage of subjects
Unable to obtain confidence interval for 0 subjects
|
0 percentage of subjects
Unable to obtain confidence interval for 0 subjects
|
0.38 percentage of subjects
Interval 0.01 to 2.08
|
Adverse Events
BIOTRONIK Corox BP LV Lead
Serious events: 281 serious events
Other events: 83 other events
Deaths: 641 deaths
Serious adverse events
| Measure |
BIOTRONIK Corox BP LV Lead
n=2499 participants at risk
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
|---|---|
|
Cardiac disorders
CHF
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Device migration
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Hypotensive arrest / hemodynamic collapse
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead T-wave oversensing
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead cardiac perforation with or without tamponade
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead dislodgement
|
1.4%
34/2499 • Number of events 34 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead high pacing threshold, intermittent capture, no lead capture
|
0.56%
14/2499 • Number of events 14 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead impedance out of range, high impedance, potential conductor fracture
|
0.60%
15/2499 • Number of events 15 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead impedance out of range, low Impedance, potential insulation break
|
0.44%
11/2499 • Number of events 11 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead inability to defibrillate or pace
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead oversensing or lead noise
|
0.40%
10/2499 • Number of events 10 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead undersensing or loss of sensing
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead, Riata lead externalized
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead, unknown, inadequate source documentation
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Inappropriate shocks
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead abnormal pacing impedance, high impedance
|
0.48%
12/2499 • Number of events 12 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead cardiac perforation with or without tamponade
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead conductor fracture
|
0.20%
5/2499 • Number of events 5 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead dislodgement
|
2.4%
61/2499 • Number of events 65 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead excess slack
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead high pacing threshold, intermittent capture, no lead capture
|
0.56%
14/2499 • Number of events 14 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead related diaphgramatic / pectoral stimulation
|
0.56%
14/2499 • Number of events 14 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Non-functioning RA lead
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Pocket pain
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead dislodgement
|
1.2%
29/2499 • Number of events 30 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead high pacing threshold, intermittent capture, no lead capture
|
0.12%
3/2499 • Number of events 3 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead impedance out of range, high impedance, potential conductor fracture
|
0.32%
8/2499 • Number of events 8 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead impedance out of range, low impedance, potential insulation break
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead oversensing or lead noise
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead undersensing or loss of sensing
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RV pacing lead dislodgement
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RV pacing lead impedance out of range, high impedance, potential conductor fracture
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RV pacing lead noise
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Suspected generator failure requiring opening of pulse generator pocket
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
General disorders
Twiddler's syndrome
|
0.28%
7/2499 • Number of events 9 • Implant to study exit (up to 5 years post-implant)
|
|
Infections and infestations
Implant procedure related infection
|
0.76%
19/2499 • Number of events 19 • Implant to study exit (up to 5 years post-implant)
|
|
Infections and infestations
Pocket infection
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Infections and infestations
Secondary infection
|
0.60%
15/2499 • Number of events 15 • Implant to study exit (up to 5 years post-implant)
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.12%
3/2499 • Number of events 3 • Implant to study exit (up to 5 years post-implant)
|
|
Skin and subcutaneous tissue disorders
Trauma related dehiscence
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Cardiac perforation with or without tamponade
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Hematoma
|
0.60%
15/2499 • Number of events 15 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
High defibrillation thresholds due to inappropriate lead placement
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Implant procedure related damage to the lead
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
LV lead dislodgement during RV lead extraction
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Loose set screw
|
0.20%
5/2499 • Number of events 5 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Non-healing pocket dehiscence requiring intervention
|
0.32%
8/2499 • Number of events 8 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Open heart surgery causing LV lead dislodgement
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Persistent arm of unknown cause
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Pneumothorax
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Pocket pain
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
RA lead dislodgement during LV lead placement
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
SVC perforation during laser lead extraction
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Subclavian vein occlusion
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
Other adverse events
| Measure |
BIOTRONIK Corox BP LV Lead
n=2499 participants at risk
Subjects consented and implanted with a BIOTRONIK Corox BP LV lead.
|
|---|---|
|
Surgical and medical procedures
Arrhythmias
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Coronary sinus dissection
|
0.12%
3/2499 • Number of events 3 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Diaphragmatic stimulation
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Hematoma
|
0.88%
22/2499 • Number of events 22 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead high pacing threshold, intermittent capture, no lead capture
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead oversensing
|
0.08%
2/2499 • Number of events 2 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
ICD lead oversensing or lead noise
|
0.16%
4/2499 • Number of events 4 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Incompletely healed incision
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead abnormal pacing impedance, high impedance
|
0.28%
7/2499 • Number of events 7 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead dislodgement
|
0.36%
9/2499 • Number of events 9 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
High pacing threshold
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead high pacing threshold, intermittent capture, no lead capture
|
0.40%
10/2499 • Number of events 10 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
LV lead related diaphgramatic / pectoral stimulation
|
0.44%
11/2499 • Number of events 11 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Left subclavian vein thrombosis
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Surgical and medical procedures
Non-healing pocket dehiscence requiring intervention
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead dislodgement
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead high pacing threshold, intermittent capture, no lead capture
|
0.12%
3/2499 • Number of events 3 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead impedance out of range, high impedance, potential conductor fracture
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead impedance out of range, low impedance, potential insulation break
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead noise
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
RA lead oversensing or lead noise
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
|
Cardiac disorders
Twiddler's syndrome
|
0.04%
1/2499 • Number of events 1 • Implant to study exit (up to 5 years post-implant)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER