Trial Outcomes & Findings for Plexa ICD Lead Registry (NCT NCT03103503)
NCT ID: NCT03103503
Last Updated: 2020-10-14
Results Overview
Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.
Recruitment status
TERMINATED
Target enrollment
901 participants
Primary outcome timeframe
Up to 2.5 years
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
BIOTRONIK Plexa ICD Lead
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Overall Study
STARTED
|
901
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
901
|
Reasons for withdrawal
| Measure |
BIOTRONIK Plexa ICD Lead
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Overall Study
Death
|
64
|
|
Overall Study
Physician Decision
|
57
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Plexa Lead or Pulse Generator Extraction
|
10
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Study Closure
|
757
|
Baseline Characteristics
Data collected and analyzed when available, not all subjects had data available for this measurement.
Baseline characteristics by cohort
| Measure |
BIOTRONIK Plexa ICD Lead
n=901 Participants
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Age, Continuous
|
64.35 years
STANDARD_DEVIATION 12.59 • n=894 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement.
|
|
Sex: Female, Male
Female
|
237 Participants
n=894 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement.
|
|
Sex: Female, Male
Male
|
657 Participants
n=894 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement.
|
|
Height
|
68.5 inches
STANDARD_DEVIATION 4.0 • n=874 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement.
|
|
Weight
|
207.2 pounds
STANDARD_DEVIATION 57.0 • n=880 Participants • Data collected and analyzed when available, not all subjects had data available for this measurement.
|
PRIMARY outcome
Timeframe: Up to 2.5 yearsEvaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.
Outcome measures
| Measure |
BIOTRONIK Plexa ICD Lead
n=901 Participants
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Percentage of Subjects Free From Plexa Lead Related Adverse Events
|
100.00 percentage of participants
Interval 99.49 to 100.0
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsPopulation: No primary outcome adverse events were reported; therefore, there are no individual events to be analyzed.
Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2.5 yearsPacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.
Outcome measures
| Measure |
BIOTRONIK Plexa ICD Lead
n=3714 visits with measurement
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Pacing Threshold Measurements for the Plexa Lead Through Study Termination
|
0.63 V
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsSensing measurements for the Plexa leads at completed follow-up visits.
Outcome measures
| Measure |
BIOTRONIK Plexa ICD Lead
n=3746 visits with measurement
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Sensing Measurements for the Plexa Lead Through Study Termination
|
15.88 mV
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsPacing impedance measurements for the Plexa leads at completed follow-up visits.
Outcome measures
| Measure |
BIOTRONIK Plexa ICD Lead
n=3925 visits with measurement
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Pacing Impedance Measurements for the Plexa Lead Through Study Termination
|
567.1 ohms
Standard Deviation 111.2
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsShock impedance measurements for the Plexa leads at completed follow-up visits.
Outcome measures
| Measure |
BIOTRONIK Plexa ICD Lead
n=3913 visits with measurement
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Shock Impedance for the Plexa Lead Through Study Termination
|
75.1 ohms
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsEvaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.
Outcome measures
| Measure |
BIOTRONIK Plexa ICD Lead
n=901 Participants
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Percentage of Subjects Free From Protocol Defined Adverse Events
|
95.12 percentage of participants
Interval 93.49 to 96.36
|
Adverse Events
BIOTRONIK Plexa ICD Lead
Serious events: 44 serious events
Other events: 12 other events
Deaths: 64 deaths
Serious adverse events
| Measure |
BIOTRONIK Plexa ICD Lead
n=901 participants at risk
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Surgical and medical procedures
Non-healing pocket dehiscence requiring intervention
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Cardiogenic shock during implantation
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Operation wound bleeding
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Venous occlusion associated with the implant procedure
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
LV lead related high pacing threshold
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
LV lead related lead dislodgement
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
General disorders
Twiddler's syndrome
|
0.22%
2/901 • Number of events 3 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related lead dislodgement
|
1.3%
12/901 • Number of events 12 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related other: high defibrillation threshold.no evidence for lead malfunction
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RA lead related lead dislodgement
|
0.55%
5/901 • Number of events 6 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
General disorders
Pulmonary Emboli
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related high pacing threshold
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related intermittent capture
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related lead impedance out of range, high
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related lead undersensing
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Hematoma
|
0.33%
3/901 • Number of events 3 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Infections and infestations
Infection
|
1.2%
11/901 • Number of events 11 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Loose set-screw
|
0.33%
3/901 • Number of events 3 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
Other adverse events
| Measure |
BIOTRONIK Plexa ICD Lead
n=901 participants at risk
Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead.
|
|---|---|
|
Surgical and medical procedures
Hematoma
|
0.22%
2/901 • Number of events 2 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Non-healing pocket dehiscence requiring intervention
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Slow wound healing, no sign for infection
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Surgical and medical procedures
Thrombosis
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
LV lead related extracardiac stimulation
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
LV lead related lead impedance out of range, high
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related lead dislodgement
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RV lead related other: positional atrial undersensing
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RA lead related lead dislodgement
|
0.11%
1/901 • Number of events 1 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
|
Cardiac disorders
RA lead related no capture
|
0.22%
2/901 • Number of events 2 • Though study exit or study termination, an average of 1.1 years
Serious adverse events were defined according to ISO14155.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place