Trial Outcomes & Findings for Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY) (NCT NCT00836589)
NCT ID: NCT00836589
Last Updated: 2019-02-15
Results Overview
The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).
Recruitment status
COMPLETED
Target enrollment
1997 participants
Primary outcome timeframe
5 years
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Data Collection Group
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
|---|---|
|
Overall Study
STARTED
|
1997
|
|
Overall Study
COMPLETED
|
731
|
|
Overall Study
NOT COMPLETED
|
1266
|
Reasons for withdrawal
| Measure |
Data Collection Group
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
246
|
|
Overall Study
Death
|
429
|
|
Overall Study
Withdrawal by Subject or Physician
|
591
|
Baseline Characteristics
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
Baseline characteristics by cohort
| Measure |
Data Collection Group
n=1997 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
|---|---|
|
Age, Customized
Age at Enrollment
|
64.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
537 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1460 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1298 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
288 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
244 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Amerian Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Height
|
68.0 in
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Weight
|
194.2 lbs
STANDARD_DEVIATION 49.4 • 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 complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).
Outcome measures
| Measure |
Data Collection Group
n=777 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead
|
90.9 percentage of subjects
Interval 88.6 to 92.8
|
—
|
—
|
—
|
—
|
—
|
—
|
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 (SAEs) contributing to primary outcome 1 and their associated SAE category.
Outcome measures
| Measure |
Data Collection Group
n=777 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Low lead impedance, potential insulation breach
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
High lead impedance, potential conductor fracture
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Lead noise or oversensing
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Lead dislodgement (>180 days post-implant)
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Lead undersensing or loss of sensing
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Inability to defibrillate or pace
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
No slack in lead due to probable dislodgement
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Noise consistent with probable fracture
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Tension pneumothorax
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY 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 secondary endpoint adverse event (ICD lead, device, implant procedure, or other related).
Outcome measures
| Measure |
Data Collection Group
n=830 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
Total related to the ICD lead
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
Total device related
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
Total implant procedure related
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
Total other AEs
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The evaluable subject population is the sum of the total unique subjects who completed the 5-year follow-up and had an RA lead implanted for any duration and/or who experienced a secondary endpoint adverse event (RA lead related).
Outcome measures
| Measure |
Data Collection Group
n=562 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.
|
39 subjects with adverse event
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 17 subjects were excluded due to incomplete data.
Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold is calculated as a mean across all study visits.
Outcome measures
| Measure |
Data Collection Group
n=1980 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
|
0.64 Volts (V)
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 17 subjects were excluded due to incomplete data.
The mean sensing measurement is calculated as a mean across all study visits.
Outcome measures
| Measure |
Data Collection Group
n=1980 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
|
12.77 millivolts (mV)
Standard Deviation 5.40
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 17 subjects were excluded due to incomplete data.
The mean pacing impedance measurement is calculated as a mean across all study visits.
Outcome measures
| Measure |
Data Collection Group
n=1980 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
|
Linox T
|
Linox TD
|
Linox Smart S
|
Linox Smart SD
|
Linox Smart TD
|
|---|---|---|---|---|---|---|---|
|
Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
|
552.9 ohms
Standard Deviation 136.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold of each Linox Lead System model was calculated as a mean across all study visits.
Outcome measures
| Measure |
Data Collection Group
n=338 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
n=1352 Participants
|
Linox T
n=1 Participants
|
Linox TD
n=88 Participants
|
Linox Smart S
n=24 Participants
|
Linox Smart SD
n=173 Participants
|
Linox Smart TD
n=4 Participants
|
|---|---|---|---|---|---|---|---|
|
Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.
|
0.62 Volts (V)
Standard Deviation 0.31
|
0.64 Volts (V)
Standard Deviation 0.33
|
0.50 Volts (V)
Standard Deviation 0.00
|
0.76 Volts (V)
Standard Deviation 0.62
|
0.59 Volts (V)
Standard Deviation 0.22
|
0.66 Volts (V)
Standard Deviation 0.46
|
0.67 Volts (V)
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 5 yearsThe mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.
Outcome measures
| Measure |
Data Collection Group
n=338 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
n=1352 Participants
|
Linox T
n=1 Participants
|
Linox TD
n=88 Participants
|
Linox Smart S
n=24 Participants
|
Linox Smart SD
n=173 Participants
|
Linox Smart TD
n=4 Participants
|
|---|---|---|---|---|---|---|---|
|
Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.
|
13.66 millivolts (mV)
Standard Deviation 5.69
|
12.71 millivolts (mV)
Standard Deviation 5.41
|
5.63 millivolts (mV)
Standard Deviation 0.81
|
10.96 millivolts (mV)
Standard Deviation 4.06
|
13.12 millivolts (mV)
Standard Deviation 5.14
|
12.25 millivolts (mV)
Standard Deviation 4.93
|
10.25 millivolts (mV)
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 5 yearsThe mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.
Outcome measures
| Measure |
Data Collection Group
n=338 Participants
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
Linox SD
n=1352 Participants
|
Linox T
n=1 Participants
|
Linox TD
n=88 Participants
|
Linox Smart S
n=24 Participants
|
Linox Smart SD
n=173 Participants
|
Linox Smart TD
n=4 Participants
|
|---|---|---|---|---|---|---|---|
|
Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.
|
550.9 ohms
Standard Deviation 105.3
|
541.8 ohms
Standard Deviation 120.5
|
812.0 ohms
Standard Deviation 202.5
|
784.8 ohms
Standard Deviation 306.2
|
541.5 ohms
Standard Deviation 106.5
|
546.0 ohms
Standard Deviation 99.2
|
734.4 ohms
Standard Deviation 253.8
|
Adverse Events
Data Collection Group
Serious events: 215 serious events
Other events: 31 other events
Deaths: 429 deaths
Serious adverse events
| Measure |
Data Collection Group
n=1997 participants at risk
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
|---|---|
|
Cardiac disorders
ICD lead dislodgement (occuring <= 180 days post-implant procedure)
|
1.2%
24/1997 • Number of events 25 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead high pacing threshold, intermittent capture, no lead capture
|
0.60%
12/1997 • Number of events 13 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead related cardiac perforation with or without tamponade
|
0.25%
5/1997 • Number of events 6 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead impedance out of range, low impedance, potential insulation break
|
1.3%
25/1997 • Number of events 25 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead impedance out of range, high impedance, potential conductor fracture
|
0.90%
18/1997 • Number of events 18 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Other ICD lead related: lead noise or oversensing
|
0.85%
17/1997 • Number of events 17 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead dislodgement (occuring > 180 days post-implant procedure)
|
0.30%
6/1997 • Number of events 6 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead undersensing or loss of sensing
|
0.10%
2/1997 • Number of events 2 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead inability to defibrillate or pace
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Other ICD lead related: no slack in the lead due to probable dislodgement
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Other ICD lead related: noise consistent with probable fracture
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Other ICD lead related: tension pneumothorax
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Pocket pain
|
0.10%
2/1997 • Number of events 2 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Unable to interrogate device
|
0.10%
2/1997 • Number of events 2 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Suspected generator failure
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Premature battery depletion, warranting device replacement
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead dislodgement
|
0.90%
18/1997 • Number of events 18 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead impedance out of range, high impedance, potential conductor fracture
|
0.10%
2/1997 • Number of events 3 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead undersensing or loss of sensing
|
0.15%
3/1997 • Number of events 3 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead oversensing or noise
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead high pacing threshold, intermittent capture, no lead capture
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead loose set screw
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Infections and infestations
Infection not due to secondary infection
|
1.4%
27/1997 • Number of events 27 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Hematoma
|
0.35%
7/1997 • Number of events 7 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Loose set screw
|
0.20%
4/1997 • Number of events 4 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Non-healing pocket dehiscence requiring intervention
|
0.15%
3/1997 • Number of events 3 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Bleeding
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Deep vein thrombosis
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Impending erosion
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Pain at insertion site
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Pocket erosion
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Pulmonary embolism (unrelated to ICD lead)
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Shock coils reversed in header
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Infections and infestations
Infection due to secondary infection
|
0.70%
14/1997 • Number of events 14 • Implant to Study Exit (up to 5 years)
|
|
General disorders
Twiddler's syndrome
|
0.25%
5/1997 • Number of events 6 • Implant to Study Exit (up to 5 years)
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Pulseless electrical activity (PEA) arrest
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
LV lead dislodgement
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
Thrombus attached to ICD lead (unrelated to ICD lead)
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
Other adverse events
| Measure |
Data Collection Group
n=1997 participants at risk
ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
|---|---|
|
Cardiac disorders
ICD lead high pacing threshold, intermittent capture, no lead capture
|
0.10%
2/1997 • Number of events 2 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
ICD lead impedance out of range, high impedance, potential conductor fracture
|
0.10%
2/1997 • Number of events 2 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead dislodgement
|
0.55%
11/1997 • Number of events 11 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead impedance out of range, high impedance, potential conductor fracture
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Cardiac disorders
RA lead oversensing or noise
|
0.10%
2/1997 • Number of events 2 • Implant to Study Exit (up to 5 years)
|
|
Infections and infestations
Infection not due to secondary infection
|
0.05%
1/1997 • Number of events 1 • Implant to Study Exit (up to 5 years)
|
|
Surgical and medical procedures
Hematoma
|
0.60%
12/1997 • Number of events 13 • Implant to Study Exit (up to 5 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators agree to submit copies of any manuscript proposed for publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests
- Publication restrictions are in place
Restriction type: OTHER