Trial Outcomes & Findings for Protego DF4 Post Approval Registry (NCT NCT02243696)
NCT ID: NCT02243696
Last Updated: 2020-06-22
Results Overview
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Recruitment status
TERMINATED
Target enrollment
1694 participants
Primary outcome timeframe
Up to 4.5 years
Results posted on
2020-06-22
Participant Flow
Participant milestones
| Measure |
BIOTRONIK Protego DF4 Lead
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Overall Study
STARTED
|
1694
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1694
|
Reasons for withdrawal
| Measure |
BIOTRONIK Protego DF4 Lead
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Overall Study
Death
|
282
|
|
Overall Study
Withdrawal by Subject
|
79
|
|
Overall Study
Lost to Follow-up
|
57
|
|
Overall Study
Subject No Longer has Study System
|
42
|
|
Overall Study
Subject Withdrawn by Investigator
|
273
|
|
Overall Study
Study Terminated for EP PASSION
|
961
|
Baseline Characteristics
Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic.
Baseline characteristics by cohort
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 12.49 • n=1694 Participants
|
|
Sex: Female, Male
Female
|
481 Participants
n=1694 Participants
|
|
Sex: Female, Male
Male
|
1213 Participants
n=1694 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
177 Participants
n=1694 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1326 Participants
n=1694 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
191 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
Black or African American
|
340 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
White
|
1130 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1694 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
181 Participants
n=1694 Participants
|
|
Weight
|
196.3 pounds
STANDARD_DEVIATION 51.28 • n=1656 Participants • Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic.
|
|
Height
|
67.7 inches
STANDARD_DEVIATION 4.11 • n=1653 Participants • Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic.
|
PRIMARY outcome
Timeframe: Up to 4.5 yearsEvaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Percentage of Subjects With No Protego DF4 Lead Adverse Event
|
98.7 percentage of participants
Interval 98.04 to 99.18
|
PRIMARY outcome
Timeframe: Up to 4.5 yearsEvaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Lead oversensing
|
0.41 percentage of participants
Interval 0.17 to 0.85
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Lead conductor fracture
|
0.30 percentage of participants
Interval 0.1 to 0.69
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Lead dislodgement
|
0.18 percentage of participants
Interval 0.03 to 0.55
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Lead impedance our of range, high
|
0.12 percentage of participants
Interval 0.01 to 0.43
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Lead impedance out of range, low
|
0.12 percentage of participants
Interval 0.01 to 0.43
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Cardiac perforation
|
0.06 percentage of participants
Interval 0.01 to 0.33
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Inability to extend helix
|
0.06 percentage of participants
Interval 0.01 to 0.33
|
|
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Lead failure
|
0.06 percentage of participants
Interval 0.01 to 0.33
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsPopulation: A threshold measurement for the Protego lead using a pulse width of 0.4 or 0.5 ms was unavailable for one subject. This patient was excluded from the analysis of this outcome measure.
Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1693 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Protego DF4 Lead Pacing Threshold Measurement
|
0.67 volts
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsShock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Protego DF4 Lead Shock Impedance
|
71.5 Ohms
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsThe overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
|
90.73 percentage of participants
Interval 89.25 to 92.07
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsSensing measurements for the Protego DF4 leads through 5 years of follow-up.
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Protego DF4 Lead Sensing
|
15.70 millivolts
Standard Deviation 5.97
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsPacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Outcome measures
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 Participants
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Protego DF4 Lead Pacing Impedance
|
552.3 Ohms
Standard Deviation 121.5
|
Adverse Events
BIOTRONIK Protego DF4 Lead
Serious events: 145 serious events
Other events: 144 other events
Deaths: 282 deaths
Serious adverse events
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 participants at risk
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Cardiac disorders
Atrial lead conductor fracture
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial lead dislodgement
|
1.2%
21/1694 • Number of events 21 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial lead high pacing threshold
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Cardiac perforation
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Inability to defibrillate successfully with the Protego lead
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead diaphragmatic stimulation
|
0.30%
5/1694 • Number of events 5 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead dislodgement
|
0.35%
6/1694 • Number of events 7 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead high pacing threshold
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead impedance out of range, high impedance
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead intermittent capture / no lead capture
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Premature battery depletion
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Pulse generator failure
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Pulse generator migration
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead conductor fracture
|
0.35%
6/1694 • Number of events 6 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead dislodgement
|
1.5%
26/1694 • Number of events 27 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead failure
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead high pacing threshold
|
0.30%
5/1694 • Number of events 5 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead impedance out of range, high impedance
|
0.30%
5/1694 • Number of events 5 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead impedance out of range, low impedance
|
0.24%
4/1694 • Number of events 4 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead intermittent capture / no lead capture
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead oversensing not due to external noise
|
0.53%
9/1694 • Number of events 9 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead undersensing or loss of sensing
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
General disorders
Pulmonary embolism
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
General disorders
Twiddler's syndrome
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Infections and infestations
Primary infection
|
1.2%
21/1694 • Number of events 21 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Infections and infestations
Secondary infection
|
0.41%
7/1694 • Number of events 7 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Cardiac perforation with or without tamponade
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Coronary sinus dissection
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Hematoma
|
0.53%
9/1694 • Number of events 9 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Loose set-screw
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Pneumothorax
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Pocket pain
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Pulmonary embolism
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Venous occlusion
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
Other adverse events
| Measure |
BIOTRONIK Protego DF4 Lead
n=1694 participants at risk
Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.
|
|---|---|
|
Cardiac disorders
Atrial lead dislodgement
|
0.30%
5/1694 • Number of events 5 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial lead high pacing threshold
|
0.77%
13/1694 • Number of events 13 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial lead impedance out of range, high impedance
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial lead impedance out of range, low impedance
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Atrial lead intermittent capture / no lead capture
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Bent connector pin noted during implant procedure
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Inability to extend helix during implant procedure
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Inability to successfully implant Protego lead
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead diaphragmatic stimulation
|
1.8%
31/1694 • Number of events 38 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead dislodgement
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead high pacing threshold
|
3.5%
59/1694 • Number of events 67 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead impedance out of range, high impedance
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead intermittent capture / no lead capture
|
0.30%
5/1694 • Number of events 6 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
LV lead oversensing not due to external noise
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
Pulse generator back-up mode initiated
|
0.30%
5/1694 • Number of events 5 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead diaphragmatic stimulation
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead high pacing threshold
|
0.59%
10/1694 • Number of events 10 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead impedance out of range, high impedance
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead impedance out of range, low impedance
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead intermittent capture / no lead capture
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead oversensing not due to external noise
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Cardiac disorders
RV lead undersensing or loss of sensing
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
General disorders
Lightheadedness
|
0.12%
2/1694 • Number of events 2 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Damage to lead during procedure (e.g. accidental cut to lead body during pocket revision, device rep
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Hematoma
|
0.18%
3/1694 • Number of events 3 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Inability to successfully implant Protego lead due to patient anatomy
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Pocket pain
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
RA lead dislodgement during a procedure
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
RV lead dislodgement during a procedure
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Venous occlusion
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
|
Surgical and medical procedures
Venous thrombosis without pulmonary embolism
|
0.06%
1/1694 • Number of events 1 • Up to 4.5 years
According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected. Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place