Patients Indicated for an ICD
Conditions
Keywords
Long-term safety and reliability of ICD leads
Brief summary
The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing pacing or defibrillation therapy.
Detailed description
This study is a multi-center, prospective, non-randomized, 5-year data collection registry. Eligible patients must have been successfully implanted with a Linox Lead System connected to a BIOTRONIK ICD and consented and enrolled between 1-45 days following implant. This study is designed to be a post-implant (office-based) registry, and patients are meant to be seen according to each institution's standard of care, but not to exceed a follow-up time frame of every 6 months. At least 2000 patients will be enrolled in this registry, and each patient will be followed for five years post-implant. Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention to resolve. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. An independent Clinical Events Committee will review and adjudicate all adverse events that occur during the study according to the protocol definitions.
Interventions
DEVICEICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Sponsors
Biotronik, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully implanted Linox Lead System connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment * Able to understand the nature of the registry and provide informed consent * Available for follow-up visits on a regular basis at the investigational site * Age greater than or equal to 18 years
Exclusion criteria
* Enrolled in any IDE clinical study * Planned cardiac surgical procedures or investigational measures within the next 6 months * Expected to receive a heart transplant within 1 year * Life expectancy less than 1 year * Presence of another life-threatening, underlying illness separate from their cardiac disorder * Pregnancy * Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead | 5 years | 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). |
| Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | 5 years | Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. | 5 years | 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. |
| Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. | 5 years | The mean sensing measurement is calculated as a mean across all study visits. |
| Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. | 5 years | The mean pacing impedance measurement is calculated as a mean across all study visits. |
| 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. | 5 years | — |
| Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 5 years | The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits. |
| Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 5 years | The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits. |
| Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 5 years | 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 of each Linox Lead System model was calculated as a mean across all study visits. |
| Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant. | 5 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Data Collection Group ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads. | 1,997 |
| Total | 1,997 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 429 |
| Overall Study | Lost to Follow-up | 246 |
| Overall Study | Withdrawal by Subject or Physician | 591 |
Baseline characteristics
| Characteristic | Data Collection Group |
|---|---|
| Age, Customized Age at Enrollment | 64.5 years STANDARD_DEVIATION 12.6 |
| Height | 68.0 in STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Race Amerian Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 21 Participants |
| Race/Ethnicity, Customized Race Black or African American | 288 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 244 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Race Unknown | 139 Participants |
| Race/Ethnicity, Customized Race White | 1298 Participants |
| Sex: Female, Male Female | 537 Participants |
| Sex: Female, Male Male | 1460 Participants |
| Weight | 194.2 lbs STANDARD_DEVIATION 49.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 429 / 1,997 |
| other Total, other adverse events | 31 / 1,997 |
| serious Total, serious adverse events | 215 / 1,997 |
Outcome results
Primary
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.
Time frame: 5 years
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Low lead impedance, potential insulation breach | 25 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | High lead impedance, potential conductor fracture | 20 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Lead noise or oversensing | 17 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Lead dislodgement (>180 days post-implant) | 6 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Lead undersensing or loss of sensing | 2 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Inability to defibrillate or pace | 1 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | No slack in lead due to probable dislodgement | 1 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Noise consistent with probable fracture | 1 Participants |
| Data Collection Group | Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type | Tension pneumothorax | 1 Participants |
Primary
Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead
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).
Time frame: 5 years
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Data Collection Group | Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead | 90.9 percentage of subjects |
p-value: 0.002Binomial Proportion
Secondary
Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.
The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Data Collection Group | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 550.9 ohms | Standard Deviation 105.3 |
| Linox SD | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 541.8 ohms | Standard Deviation 120.5 |
| Linox T | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 812.0 ohms | Standard Deviation 202.5 |
| Linox TD | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 784.8 ohms | Standard Deviation 306.2 |
| Linox Smart S | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 541.5 ohms | Standard Deviation 106.5 |
| Linox Smart SD | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 546.0 ohms | Standard Deviation 99.2 |
| Linox Smart TD | Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. | 734.4 ohms | Standard Deviation 253.8 |
Secondary
Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.
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 of each Linox Lead System model was calculated as a mean across all study visits.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Data Collection Group | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.62 Volts (V) | Standard Deviation 0.31 |
| Linox SD | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.64 Volts (V) | Standard Deviation 0.33 |
| Linox T | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.50 Volts (V) | Standard Deviation 0 |
| Linox TD | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.76 Volts (V) | Standard Deviation 0.62 |
| Linox Smart S | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.59 Volts (V) | Standard Deviation 0.22 |
| Linox Smart SD | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.66 Volts (V) | Standard Deviation 0.46 |
| Linox Smart TD | Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. | 0.67 Volts (V) | Standard Deviation 0.31 |
Secondary
Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.
The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Data Collection Group | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 13.66 millivolts (mV) | Standard Deviation 5.69 |
| Linox SD | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 12.71 millivolts (mV) | Standard Deviation 5.41 |
| Linox T | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 5.63 millivolts (mV) | Standard Deviation 0.81 |
| Linox TD | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 10.96 millivolts (mV) | Standard Deviation 4.06 |
| Linox Smart S | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 13.12 millivolts (mV) | Standard Deviation 5.14 |
| Linox Smart SD | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 12.25 millivolts (mV) | Standard Deviation 4.93 |
| Linox Smart TD | Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. | 10.25 millivolts (mV) | Standard Deviation 1.46 |
Secondary
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.
Time frame: 5 years
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Data Collection Group | 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 |
| Data Collection Group | 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 |
| Data Collection Group | 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 |
| Data Collection Group | 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
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.
Time frame: 5 years
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Data Collection Group | 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
Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
The mean pacing impedance measurement is calculated as a mean across all study visits.
Time frame: 5 years
Population: 17 subjects were excluded due to incomplete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Data Collection Group | 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
Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
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.
Time frame: 5 years
Population: 17 subjects were excluded due to incomplete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Data Collection Group | 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
Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
The mean sensing measurement is calculated as a mean across all study visits.
Time frame: 5 years
Population: 17 subjects were excluded due to incomplete data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Data Collection Group | Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. | 12.77 millivolts (mV) | Standard Deviation 5.4 |