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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data Collection Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD Therapy - ICD Lead Registry | Device | Collecting long-term safety and efficacy data on a family of market-released ICD leads. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 years |
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albertville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26990515 | Derived | Good ED, Cakulev I, Orlov MV, Hirsh D, Simeles J, Mohr K, Moll P, Bloom H. Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads. J Cardiovasc Electrophysiol. 2016 Jun;27(6):735-42. doi: 10.1111/jce.12971. Epub 2016 May 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Data Collection Group | ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| 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. | 5 years |
| Birmingham |
| Alabama |
| United States |
| Gadsden | Alabama | United States |
| Jasper | Alabama | United States |
| Glendale | Arizona | United States |
| Mesa | Arizona | United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Tucson | Arizona | United States |
| Burbank | California | United States |
| Fairfield | California | United States |
| Fountain Valley | California | United States |
| Glendale | California | United States |
| Hawthorne | California | United States |
| Inglewood | California | United States |
| Los Angeles | California | United States |
| Mission Viejo | California | United States |
| Northridge | California | United States |
| Rancho Mirage | California | United States |
| Santa Barbara | California | United States |
| Santa Maria | California | United States |
| Torrance | California | United States |
| Aurora | Colorado | United States |
| Boulder | Colorado | United States |
| Brooksville | Florida | United States |
| Daytona Beach | Florida | United States |
| Inverness | Florida | United States |
| Jacksonville | Florida | United States |
| Melbourne | Florida | United States |
| Miami | Florida | United States |
| Naples | Florida | United States |
| New Smyrna Beach | Florida | United States |
| Pensacola | Florida | United States |
| Port Charlotte | Florida | United States |
| Atlanta | Georgia | United States |
| Alton | Illinois | United States |
| Centralia | Illinois | United States |
| Chicago | Illinois | United States |
| Hammond | Indiana | United States |
| Jeffersonville | Indiana | United States |
| Owensboro | Kentucky | United States |
| Lafayette | Louisiana | United States |
| Lake Charles | Louisiana | United States |
| Marrero | Louisiana | United States |
| Baltimore | Maryland | United States |
| Cumberland | Maryland | United States |
| Rockville | Maryland | United States |
| Salisbury | Maryland | United States |
| Grand Rapids | Michigan | United States |
| Ypsilanti | Michigan | United States |
| Biloxi | Mississippi | United States |
| Bridgeton | Missouri | United States |
| Crystal City | Missouri | United States |
| St Louis | Missouri | United States |
| Haddon Heights | New Jersey | United States |
| Rochester | New York | United States |
| Charlotte | North Carolina | United States |
| Concord | North Carolina | United States |
| Gastonia | North Carolina | United States |
| Greensboro | North Carolina | United States |
| Grand Forks | North Dakota | United States |
| Columbus | Ohio | United States |
| Massillon | Ohio | United States |
| Toledo | Ohio | United States |
| Zanesville | Ohio | United States |
| Salem | Oregon | United States |
| Tualatin | Oregon | United States |
| Chinchilla | Pennsylvania | United States |
| Phoenixville | Pennsylvania | United States |
| Yardley | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Florence | South Carolina | United States |
| Greenville | South Carolina | United States |
| Greenwood | South Carolina | United States |
| Lancaster | South Carolina | United States |
| Rock Hill | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Amarillo | Texas | United States |
| El Paso | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Kingwood | Texas | United States |
| McAllen | Texas | United States |
| McKinney | Texas | United States |
| Yakima | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Data Collection Group | ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | in |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | lbs |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | No | 5 years |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Count of Participants | Participants | No | 5 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant. | 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). | Posted | Number | subjects with adverse event | 5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 17 subjects were excluded due to incomplete data. | Posted | Mean | Standard Deviation | Volts (V) | 5 years |
|
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| 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. | 17 subjects were excluded due to incomplete data. | Posted | Mean | Standard Deviation | millivolts (mV) | 5 years |
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| 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. | 17 subjects were excluded due to incomplete data. | Posted | Mean | Standard Deviation | ohms | 5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Volts (V) | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | millivolts (mV) | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | ohms | 5 years |
|
Implant to Study Exit (up to 5 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Data Collection Group | ICD Therapy - ICD Lead Registry: Collecting long-term safety and efficacy data on a family of market-released ICD leads. | 429 | 1,997 | 215 | 1,997 | 31 | 1,997 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICD lead dislodgement (occuring <= 180 days post-implant procedure) | Cardiac disorders |
| |||
| ICD lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders |
| |||
| ICD lead related cardiac perforation with or without tamponade | Cardiac disorders |
| |||
| ICD lead impedance out of range, low impedance, potential insulation break | Cardiac disorders |
| |||
| ICD lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders |
| |||
| Other ICD lead related: lead noise or oversensing | Cardiac disorders |
| |||
| ICD lead dislodgement (occuring > 180 days post-implant procedure) | Cardiac disorders |
| |||
| ICD lead undersensing or loss of sensing | Cardiac disorders |
| |||
| ICD lead inability to defibrillate or pace | Cardiac disorders |
| |||
| Other ICD lead related: no slack in the lead due to probable dislodgement | Cardiac disorders |
| |||
| Other ICD lead related: noise consistent with probable fracture | Cardiac disorders |
| |||
| Other ICD lead related: tension pneumothorax | Cardiac disorders |
| |||
| Pocket pain | Cardiac disorders |
| |||
| Unable to interrogate device | Cardiac disorders |
| |||
| Suspected generator failure | Cardiac disorders |
| |||
| Premature battery depletion, warranting device replacement | Cardiac disorders |
| |||
| RA lead dislodgement | Cardiac disorders |
| |||
| RA lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders |
| |||
| RA lead undersensing or loss of sensing | Cardiac disorders |
| |||
| RA lead oversensing or noise | Cardiac disorders |
| |||
| RA lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders |
| |||
| RA lead loose set screw | Cardiac disorders |
| |||
| Infection not due to secondary infection | Infections and infestations |
| |||
| Hematoma | Surgical and medical procedures |
| |||
| Loose set screw | Surgical and medical procedures |
| |||
| Non-healing pocket dehiscence requiring intervention | Surgical and medical procedures |
| |||
| Bleeding | Surgical and medical procedures |
| |||
| Deep vein thrombosis | Surgical and medical procedures |
| |||
| Impending erosion | Surgical and medical procedures |
| |||
| Pain at insertion site | Surgical and medical procedures |
| |||
| Pocket erosion | Surgical and medical procedures |
| |||
| Pulmonary embolism (unrelated to ICD lead) | Surgical and medical procedures |
| |||
| Shock coils reversed in header | Surgical and medical procedures |
| |||
| Infection due to secondary infection | Infections and infestations |
| |||
| Twiddler's syndrome | General disorders |
| |||
| Skin erosion | Skin and subcutaneous tissue disorders |
| |||
| Pulseless electrical activity (PEA) arrest | Cardiac disorders |
| |||
| LV lead dislodgement | Cardiac disorders |
| |||
| Thrombus attached to ICD lead (unrelated to ICD lead) | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICD lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders |
| |||
| ICD lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders |
| |||
| RA lead dislodgement | Cardiac disorders |
| |||
| RA lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders |
| |||
| RA lead oversensing or noise | Cardiac disorders |
| |||
| Infection not due to secondary infection | Infections and infestations |
| |||
| Hematoma | Surgical and medical procedures |
|
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Mohr | BIOTRONIK, INC | 800-547-0394 | kelly.mohr@biotronik.com |
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| Native Hawaiian or Other Pacific Islander |
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| Amerian Indian or Alaska Native |
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