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The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.
This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2500 patients will be enrolled in this post-approval 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. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. Reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Data Collection Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT Therapy - LV Lead Registry | Device | Collecting long-term safety and efficacy data on a market-released left ventricular lead. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead | The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR). | 5 years |
| Percentage of Subjects Experiencing Individual Complications | Evaluation of the individual types of serious adverse events contributing to primary outcome 1. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. | Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant. | 5 years |
| Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | 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 | BIOTRONIK Corox BP LV Lead | Subjects consented and implanted with a BIOTRONIK Corox BP LV lead. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2010 | Aug 30, 2019 |
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Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant. |
| 5 years |
| Corox BP LV Lead Pacing Threshold Measurements | Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. | 5 years |
| Corox BP LV Lead Sensing Measurements | Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. | 5 years |
| Corox BP LV Lead Impedance Measurements | Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. | 5 years |
| Pacing Threshold Measurements Per Corox BP LV Lead Model | Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. | 5 years |
| Sensing Measurements Per Corox BP LV Lead Model | Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. | 5 years |
| Impedance Measurements Per Corox BP LV Lead Model | Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. | 5 years |
| Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model | Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model. | 5 years |
| Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model. | 5 years |
| Glendale |
| Arizona |
| United States |
| Mesa | Arizona | United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Tucson | Arizona | United States |
| Anaheim | 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 |
| National City | California | United States |
| Northridge | California | United States |
| Orange | California | United States |
| Rancho Mirage | California | United States |
| Santa Barbara | California | United States |
| Torrance | California | United States |
| Ventura | California | United States |
| Watsonville | California | United States |
| Aurora | Colorado | United States |
| Boulder | Colorado | United States |
| Danbury | Connecticut | United States |
| Brooksville | Florida | United States |
| Davenport | Florida | United States |
| Melbourne | Florida | United States |
| Naples | Florida | United States |
| New Smyrna Beach | Florida | United States |
| St. Petersburg | Florida | United States |
| Tampa | Florida | United States |
| Macon | Georgia | United States |
| Urbana | Illinois | United States |
| Fort Wayne | Indiana | United States |
| Valparaiso | Indiana | United States |
| Owensboro | Kentucky | United States |
| Covington | Louisiana | United States |
| Hammond | Louisiana | United States |
| Lafayette | Louisiana | United States |
| Bangor | Maine | United States |
| Baltimore | Maryland | United States |
| Cumberland | Maryland | United States |
| Lanham | Maryland | United States |
| Rockville | Maryland | United States |
| Burlington | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Lansing | Michigan | United States |
| Lapeer | Michigan | United States |
| Saginaw | Michigan | United States |
| Wyoming | Michigan | United States |
| Ypsilanti | Michigan | United States |
| Tupelo | Mississippi | United States |
| Crystal City | Missouri | United States |
| St Louis | Missouri | United States |
| Las Vegas | Nevada | United States |
| Glen Ridge | New Jersey | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Gastonia | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Columbus | Ohio | United States |
| Middletown | Ohio | United States |
| Steubenville | Ohio | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Salem | Oregon | United States |
| Chinchilla | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pottstown | Pennsylvania | United States |
| Yardley | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Greenville | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Amarillo | Texas | United States |
| Brownsville | Texas | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| Kingwood | Texas | United States |
| McKinney | Texas | United States |
| Nacogdoches | Texas | United States |
| Fredericksburg | Virginia | United States |
| Spokane | Washington | United States |
| Yakima | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics are provided when available, subjects without available baseline characteristics are not included in the number of participants analyzed in this section.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BIOTRONIK Corox BP LV Lead | Subjects consented and implanted with a BIOTRONIK Corox BP LV lead. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | inches |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | pounds |
|
| 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 Corox LV Lead | The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.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 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Experiencing Individual Complications | Evaluation of the individual types of serious adverse events contributing to primary outcome 1. | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. | Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant. | The subjects analyzed in this outcome must have been consented, implanted with a BIOTRONIK Corox BP LV lead, and completed an in-office 5 year visit. Subjects who did not complete an in-office 5 year visit are excluded from this analysis population. | Posted | Mean | Standard Deviation | percentage of CRT pacing | 5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint | Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant. | Posted | Number | Percent of subjects | 5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Corox BP LV Lead Pacing Threshold Measurements | Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. | Posted | Mean | Standard Deviation | V | 5 years |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Corox BP LV Lead Sensing Measurements | Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. | Posted | Mean | Standard Deviation | mV | 5 years |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Corox BP LV Lead Impedance Measurements | Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant. | Posted | Mean | Standard Deviation | ohms | 5 years |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pacing Threshold Measurements Per Corox BP LV Lead Model | Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. | Posted | Mean | Standard Deviation | V | 5 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensing Measurements Per Corox BP LV Lead Model | Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. | Posted | Mean | Standard Deviation | mV | 5 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Impedance Measurements Per Corox BP LV Lead Model | Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead. | Posted | Mean | Standard Deviation | ohms | 5 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model | Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model. | The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model | Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model. | The evaluable subject population for each group is the sum of the total unique subjects who completed the 5-year follow-up and/or who experienced a primary endpoint adverse event in the group. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
|
|
Implant to study exit (up to 5 years post-implant)
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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 | BIOTRONIK Corox BP LV Lead | Subjects consented and implanted with a BIOTRONIK Corox BP LV lead. | 641 | 2,499 | 281 | 2,499 | 83 | 2,499 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHF | Cardiac disorders | Systematic Assessment |
| ||
| Device migration | Cardiac disorders | Systematic Assessment |
| ||
| Hypotensive arrest / hemodynamic collapse | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead T-wave oversensing | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead cardiac perforation with or without tamponade | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead impedance out of range, low Impedance, potential insulation break | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead inability to defibrillate or pace | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead oversensing or lead noise | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead undersensing or loss of sensing | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead, Riata lead externalized | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead, unknown, inadequate source documentation | Cardiac disorders | Systematic Assessment |
| ||
| Inappropriate shocks | Cardiac disorders | Systematic Assessment |
| ||
| LV lead abnormal pacing impedance, high impedance | Cardiac disorders | Systematic Assessment |
| ||
| LV lead cardiac perforation with or without tamponade | Cardiac disorders | Systematic Assessment |
| ||
| LV lead conductor fracture | Cardiac disorders | Systematic Assessment |
| ||
| LV lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| LV lead excess slack | Cardiac disorders | Systematic Assessment |
| ||
| LV lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| LV lead related diaphgramatic / pectoral stimulation | Cardiac disorders | Systematic Assessment |
| ||
| Non-functioning RA lead | Cardiac disorders | Systematic Assessment |
| ||
| Pocket pain | Cardiac disorders | Systematic Assessment |
| ||
| RA lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| RA lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| RA lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders | Systematic Assessment |
| ||
| RA lead impedance out of range, low impedance, potential insulation break | Cardiac disorders | Systematic Assessment |
| ||
| RA lead oversensing or lead noise | Cardiac disorders | Systematic Assessment |
| ||
| RA lead undersensing or loss of sensing | Cardiac disorders | Systematic Assessment |
| ||
| RV pacing lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| RV pacing lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders | Systematic Assessment |
| ||
| RV pacing lead noise | Cardiac disorders | Systematic Assessment |
| ||
| Suspected generator failure requiring opening of pulse generator pocket | Cardiac disorders | Systematic Assessment |
| ||
| Twiddler's syndrome | General disorders | Systematic Assessment |
| ||
| Implant procedure related infection | Infections and infestations | Systematic Assessment |
| ||
| Pocket infection | Infections and infestations | Systematic Assessment |
| ||
| Secondary infection | Infections and infestations | Systematic Assessment |
| ||
| Skin erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Trauma related dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Cardiac perforation with or without tamponade | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| High defibrillation thresholds due to inappropriate lead placement | Surgical and medical procedures | Systematic Assessment |
| ||
| Implant procedure related damage to the lead | Surgical and medical procedures | Systematic Assessment |
| ||
| LV lead dislodgement during RV lead extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Loose set screw | Surgical and medical procedures | Systematic Assessment |
| ||
| Non-healing pocket dehiscence requiring intervention | Surgical and medical procedures | Systematic Assessment |
| ||
| Open heart surgery causing LV lead dislodgement | Surgical and medical procedures | Systematic Assessment |
| ||
| Persistent arm of unknown cause | Surgical and medical procedures | Systematic Assessment |
| ||
| Pneumothorax | Surgical and medical procedures | Systematic Assessment |
| ||
| Pocket pain | Surgical and medical procedures | Systematic Assessment |
| ||
| RA lead dislodgement during LV lead placement | Surgical and medical procedures | Systematic Assessment |
| ||
| SVC perforation during laser lead extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Subclavian vein occlusion | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmias | Surgical and medical procedures | Systematic Assessment |
| ||
| Coronary sinus dissection | Surgical and medical procedures | Systematic Assessment |
| ||
| Diaphragmatic stimulation | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematoma | Surgical and medical procedures | Systematic Assessment |
| ||
| ICD lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead oversensing | Cardiac disorders | Systematic Assessment |
| ||
| ICD lead oversensing or lead noise | Cardiac disorders | Systematic Assessment |
| ||
| Incompletely healed incision | Surgical and medical procedures | Systematic Assessment |
| ||
| LV lead abnormal pacing impedance, high impedance | Cardiac disorders | Systematic Assessment |
| ||
| LV lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| High pacing threshold | Cardiac disorders | Systematic Assessment |
| ||
| LV lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| LV lead related diaphgramatic / pectoral stimulation | Cardiac disorders | Systematic Assessment |
| ||
| Left subclavian vein thrombosis | Surgical and medical procedures | Systematic Assessment |
| ||
| Non-healing pocket dehiscence requiring intervention | Surgical and medical procedures | Systematic Assessment |
| ||
| RA lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| RA lead high pacing threshold, intermittent capture, no lead capture | Cardiac disorders | Systematic Assessment |
| ||
| RA lead impedance out of range, high impedance, potential conductor fracture | Cardiac disorders | Systematic Assessment |
| ||
| RA lead impedance out of range, low impedance, potential insulation break | Cardiac disorders | Systematic Assessment |
| ||
| RA lead noise | Cardiac disorders | Systematic Assessment |
| ||
| RA lead oversensing or lead noise | Cardiac disorders | Systematic Assessment |
| ||
| Twiddler's syndrome | Cardiac disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Engineer Group Manager | BIOTRONIK | 800-547-0394 | celestial@biotronik.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2019 | Aug 30, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Unknown |
|
| Not Reported |
|
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| LV lead cardiac perforation |
| |||||
| LV lead high pacing threshold, no lead capture |
| |||||
| LV lead diaphragmatic / pectoral stimulation |
| |||||
| LV lead dislodgement (<180 days post-implant) |
| |||||
| RV pacing lead related adverse event |
| |||||
| Device related adverse event |
| |||||
| Other adverse event |
| |||||
| RA lead related adverse event |
| |||||
| Implant procedure related adverse event |
| |||||
| ICD lead related adverse event |
| |||||
| Other high pacing threshold |
|
| Denominators |
|---|
| Categories |
|---|
|
| Categories |
|---|
|
| Categories |
|---|
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