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| ID | Type | Description | Link |
|---|---|---|---|
| CRD-619 | Other Identifier | St. Jude Medical |
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The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).
The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following St. Jude Medical (SJM) cardiac leads: Riata leads, Riata ST leads, Durata and/or QuickSite/QuickFlex Cardiac Resynchronization Therapy (CRT) leads.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with SJM leads implanted | Patient has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads | Device | Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010 Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Leads With Electrical Dysfunction | The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups. | This outcome is assessed at enrollment and over the course of 3 years of follow-up |
| Number of Leads With Externalized Conductors | The prevalence of externalized conductors was calculated as the number of leads that have been shown to have externalized conductors by imaging at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups | This outcome is assessed at enrollment |
| Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities) | The prevalence of other visual lead anomalies (by each subcategory) was calculated as the number of leads that have been shown to have other visual anomaly (by each subcategory) at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups. | This outcome is assessed at enrollment |
| The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years. | This outcome is assessed from enrollment through the course of 3 years of follow-up |
| The Annual Hazard Rate of New Cases of Externalized Conductors (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant | Kaplan-Meier analysis of time from externalized conductors (EC) to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting EC | This outcome is assessed from time of detecting EC till the course of 3 years of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that have a market released St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D) already implanted and also have at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, P.C. | Birmingham | Alabama | 35211 | United States | ||
| University Hospital of Alabama at Birmingham |
A subject that has at least one market released lead implanted was eligible for enrollment in the study. Subjects could have more than one study lead implanted. Each lead group was considered separately for independent analyses.
The study enrolled a total of 2,216 subjects at 45 sites to achieve an evaluable sample size of at least 1,401 subjects. The first subject enrolled in this study on March 20, 2013 and enrollment was completed in June, 2016 with the last follow-up completed in June 13 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | Durata Leads | Durata leads implanted between 2008-2010 |
| FG001 | Riata Leads | Riata leads implanted between 2002-2009 |
| 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_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 18, 2015 |
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|
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from enrollment to year 1
| year 1 follow-up |
| The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 1 to year 2 | year 1 to year 2 follow-up |
| The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 2 to year 3 | year 2 to year 3 follow-up |
| The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads | Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from enrollment to year 1 | This outcome is assessed from enrollment to year 1 |
| The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads | Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 1 to year 2 | This outcome is assessed from year 1 to year 2 of follow-up |
| The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads | Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 2 to year 3 | This outcome is assessed from year 2 to year 3 follow-up |
| Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant | Kaplan-Meier analysis of time from other visual lead anomaly to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting other visual lead anomaly | This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up |
| Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). | Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group | within 30 days associated with study lead related interventions |
| Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant | time from externalized conductors to clinical intervention for all lead subgroups. | This outcome is assessed from time of detection of externalized conductor to 3 years follow-up |
| Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant | Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention | This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up |
| Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) | Comparison of patients with EC to those without EC: lead size effect on number of patients with or without EC (7F and 8F are lead sizes, F = French). Riata leads have 8F diameter and Riata ST leads have 7F diameter. The Riata/Riata ST families of leads were used for this comparison only to determine whether the difference in lead size (with the silicon material and other lead design factors controlled for) had an effect on externalization of conductors. | This outcome is assessed from enrollment till the course of 3 years of follow-up |
| Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED). | Comparison of patients with ED to those without ED: subject age effect on ED | This outcome is assessed from enrollment till the course of 3 years of follow-up |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| Heart Center Research | Huntsville | Alabama | 35801 | United States |
| Arizona Arrhythmia Consultants | Scottsdale | Arizona | 85251 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Scripps Green Hospital | La Jolla | California | 92037 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Cardiac Rhythm Specialists | Reseda | California | 91335 | United States |
| Mercy Medical Group | Sacramento | California | 95819 | United States |
| St. Joseph's Medical Center | Stockton | California | 95204 | United States |
| Penrose St. Francis Health Services | Colorado Springs | Colorado | 80907 | United States |
| Naples Heart Rhytm Specialists, PA | Naples | Florida | 34119 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| OSF Healthcare Cardiovascular Institute | Peoria | Illinois | 61614 | United States |
| Mid-America Cardiology Associates, PC | Kansas City | Kansas | 66160 | United States |
| Heart Clinic of Hammond, LLC | Hammond | Louisiana | 70403 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Cardiology Associates of North Mississippi | Tupelo | Mississippi | 38801 | United States |
| Methodist Physicians Clinic-Heart Consultants | Omaha | Nebraska | 68114 | United States |
| Deborah Heart and Lung | Browns Mills | New Jersey | 08015 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| The Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Providence Heart & Vascular Institute | Portland | Oregon | 97225 | United States |
| Saint Vincent Consultants in Cardiovascular Diseases | Erie | Pennsylvania | 16502 | United States |
| Drexel University College oF Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania | 18840 | United States |
| Wellspan Health | York | Pennsylvania | 17403 | United States |
| Sutherland Cardiology Clinic | Germantown | Tennessee | 38138 | United States |
| Mountain States Medical Group Cardiology | Johnson City | Tennessee | 37601 | United States |
| Arrhythmia Consultants | Memphis | Tennessee | 38104 | United States |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| QE II Health Sciences | Halifax | Nova Scotia | B3H 3A7 | Canada |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 545-8565 | Japan |
| Kyoto-Katsura Hospital | Kyoto | 615 8256 | Japan |
| FG002 | Riata ST | Riata ST leads implanted 2006-2009 |
| FG003 | QuickSite/QuickFlex | QuickSite/QuickFlex implanted 2006-2010 |
| COMPLETED |
|
| NOT COMPLETED |
|
The study enrolled a total of 2,216 study participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Enrolled in the Study | Demographics for all enrolled patients (N=2216) |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Number of Leads With Electrical Dysfunction | The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups. | All SJM leads enrolled in the study with Durata, Riata, Riata ST, or QuickSite/QuickFlex leads | Posted | Count of Units | implanted leads | This outcome is assessed at enrollment and over the course of 3 years of follow-up | implanted leads | implanted leads |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Leads With Externalized Conductors | The prevalence of externalized conductors was calculated as the number of leads that have been shown to have externalized conductors by imaging at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups | All SJM leads enrolled in the study with Durata, Riata, Riata ST, or QuickSite/QuickFlex leads | Posted | Count of Units | implanted leads | This outcome is assessed at enrollment | implanted leads | implanted leads |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities) | The prevalence of other visual lead anomalies (by each subcategory) was calculated as the number of leads that have been shown to have other visual anomaly (by each subcategory) at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups. | Posted | Count of Units | implanted leads | This outcome is assessed at enrollment | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years. | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | leads with electrical dysfunction/years | This outcome is assessed from enrollment through the course of 3 years of follow-up | implanted leads | implanted leads |
| |||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of New Cases of Externalized Conductors (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from enrollment to year 1 | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | 95% Confidence Interval | leads with externalized conductors/years | year 1 follow-up | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 1 to year 2 | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | 95% Confidence Interval | leads with externalized conductors/years | year 1 to year 2 follow-up | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 2 to year 3 | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | 95% Confidence Interval | leads with externalized conductors/years | year 2 to year 3 follow-up | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads | Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from enrollment to year 1 | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | 95% Confidence Interval | leads w other visual lead anomaly/years | This outcome is assessed from enrollment to year 1 | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads | Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 1 to year 2 | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | 95% Confidence Interval | leads w other visual lead anomaly/years | This outcome is assessed from year 1 to year 2 of follow-up | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||
| Primary | The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads | Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 2 to year 3 | The annual hazard rate was assessed separately in each of the 4 lead groups. | Posted | Number | 95% Confidence Interval | leads w other visual lead anomaly/years | This outcome is assessed from year 2 to year 3 follow-up | implanted leads | implanted leads |
| ||||||||||||||||||||||||||||||||||
| Secondary | Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant | Kaplan-Meier analysis of time from externalized conductors (EC) to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting EC | N at risk from detecting externalized conductors at each follow-up time point | Posted | Number | lead anomaly events | This outcome is assessed from time of detecting EC till the course of 3 years of follow-up | Implant Leads | Implant Leads |
| |||||||||||||||||||||||||||||||||||
| Secondary | Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant | Kaplan-Meier analysis of time from other visual lead anomaly to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting other visual lead anomaly | N at risk from detecting other visual lead anomaly | Posted | Number | lead anomaly events | This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up | Implant Leads | Implant Leads |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other). | Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group | Subject has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted | Posted | Count of Participants | Participants | within 30 days associated with study lead related interventions |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant | time from externalized conductors to clinical intervention for all lead subgroups. | N at risk from time of externalized conductors at each follow-up period | Posted | Number | lead anomaly events | This outcome is assessed from time of detection of externalized conductor to 3 years follow-up | Implant Leads | Implant Leads |
| |||||||||||||||||||||||||||||||||||
| Secondary | Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant | Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention | N at risk from time of detecting visual lead anomaly at each follow-up period | Posted | Number | lead anomaly events | This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up | Implant Leads | Implant Leads |
| |||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC) | Comparison of patients with EC to those without EC: lead size effect on number of patients with or without EC (7F and 8F are lead sizes, F = French). Riata leads have 8F diameter and Riata ST leads have 7F diameter. The Riata/Riata ST families of leads were used for this comparison only to determine whether the difference in lead size (with the silicon material and other lead design factors controlled for) had an effect on externalization of conductors. | Patients with Riata or Riata ST leads. | Posted | Count of Participants | Participants | This outcome is assessed from enrollment till the course of 3 years of follow-up |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED). | Comparison of patients with ED to those without ED: subject age effect on ED | Patients implanted with SJM Riata, Riata ST, Durata, or QuickSite/QuickFlex leads. Leads were combined for this analysis to compare patient groups with and without electrical dysfunction based on age (irrespective of lead implant type) | Posted | Mean | Standard Deviation | years | This outcome is assessed from enrollment till the course of 3 years of follow-up |
|
|
From enrollment to 3 years of follow-up period
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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 | Durata Leads | Subjects implanted with SJM Durata leads | 130 | 982 | 26 | 982 | 20 | 982 |
| EG001 | Riata Leads | Subjects implanted with Riata leads | 111 | 670 | 28 | 670 | 14 | 670 |
| EG002 | Riata ST Leads | Subjects implanted with Riata ST leads | 64 | 458 | 22 | 458 | 9 | 458 |
| EG003 | QuickSite/QuickFlex Leads | Subjects implanted with QuickSite/QuickFlex leads | 135 | 737 | 7 | 737 | 11 | 737 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal high voltage lead impredance | Product Issues | Systematic Assessment |
| ||
| Abnormal Pacing Impedance | Product Issues | Systematic Assessment |
| ||
| Decline in R Wave Sensing | Product Issues | Systematic Assessment |
| ||
| Elevated pacing thresholds | Product Issues | Systematic Assessment |
| ||
| Externalized Conductor | Product Issues | Systematic Assessment |
| ||
| Lead dislodgement or migration | Product Issues | Systematic Assessment |
| ||
| lead fracture | Product Issues | Systematic Assessment |
| ||
| lead insulation damage | Product Issues | Systematic Assessment |
| ||
| lead noise | Product Issues | Systematic Assessment |
| ||
| oversensing | Product Issues | Systematic Assessment |
| ||
| phrenic nerve/diaphragmatic stimulation | Product Issues | Systematic Assessment |
| ||
| shock due to AF with RVR | Product Issues | Systematic Assessment |
| ||
| undersensing | Product Issues | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal High Voltage Lead Impedance | Product Issues | Systematic Assessment |
| ||
| Abnormal Pacing Impedance | Product Issues | Systematic Assessment |
| ||
| Decrease R Wave | Product Issues | Systematic Assessment |
| ||
| Elevated pacing thresholds | Product Issues | Systematic Assessment |
| ||
| Lead Insulation Damage | Product Issues | Systematic Assessment |
| ||
| Lead Noise | Product Issues | Systematic Assessment |
| ||
| Loss of Capture | Product Issues | Systematic Assessment |
| ||
| Loss of Sensing | Product Issues | Systematic Assessment |
| ||
| Other Visual Lead Anomalies | Product Issues | Systematic Assessment |
| ||
| Oversensing | Product Issues | Systematic Assessment |
| ||
| Oversensing Resulting in Therapy | Product Issues | Systematic Assessment |
| ||
| Pectoral Stimulation | Product Issues | Systematic Assessment |
| ||
| Phrenic Nerve/Diaphragmatic Stimulation | Product Issues | Systematic Assessment |
| ||
| Therapy for Non-Ventricular Rhythm | Product Issues | Systematic Assessment |
| ||
| Undersensing | Product Issues | Systematic Assessment |
|
The sponsor can review results communications prior to public release and embargo communications regarding trial results for 12 months from study completion date to allow time for multi-center study publication. After this period, the PI shall submit to sponsor for review a copy of any proposed manuscript at least 30 days prior to the estimated date of submission for publication. Sponsor may require delay of publication not to exceed 60 days for the purpose of filing patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim, Program Director - Traditional Cardiac Rhythm Management | Abbott | 818-493-3147 | grant.kim1@abbott.com |
| Oct 22, 2020 |
| Prot_SAP_ICF_000.pdf |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
| implanted leads |
|
| Units | Counts |
|---|---|
| Participants |
|
| implanted leads |
|
|
| Units | Counts |
|---|
| Participants |
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| implanted leads |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| implanted leads |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| implanted leads |
|
|
| Units | Counts |
|---|---|
| Participants |
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| implanted leads |
|
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| Units | Counts |
|---|---|
| Participants |
|
| implanted leads |
|
|
|
|
|
|
|
|
| OG004 | Riata Leads Lead Age: 6-less Than 7 Years | lead age: 6-less than 7 years |
| OG005 | Riata Leads Lead Age: 7 Years or Greater | lead age: 7 years or greater |
| OG006 | Riata ST Lead Age: Less Than 5.5 Years | lead age: less than 5.5 years |
| OG007 | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | lead age: greater than or equal to 5.5 years |
| OG008 | QuickSite/QuickFlex Lead Age: Less Than 5 Years | lead age: less than 5 years |
| OG009 | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | lead age: 5 to less than 6 years |
| OG010 | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years | lead age: greater than or equal to 6 years |
|
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| OG004 | Riata Leads Lead Age: 6-less Than 7 Years | lead age: 6-less than 7 years |
| OG005 | Riata Leads Lead Age: 7 Years or Greater | lead age: 7 years or greater |
| OG006 | Riata ST Lead Age: Less Than 5.5 Years | lead age: less than 5.5 years |
| OG007 | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | lead age: greater than or equal to 5.5 years |
| OG008 | QuickSite/QuickFlex Lead Age: Less Than 5 Years | lead age: less than 5 years |
| OG009 | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | lead age: 5 to less than 6 years |
| OG010 | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years | lead age: greater than or equal to 6 years |
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| Units | Counts |
|---|---|
| Participants |
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| Riata Leads Lead Age: 6-less Than 7 Years |
lead age: 6-less than 7 years |
| OG005 | Riata Leads Lead Age: 7 Years or Greater | lead age: 7 years or greater |
| OG006 | Riata ST Lead Age: Less Than 5.5 Years | lead age: less than 5.5 years |
| OG007 | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | lead age: greater than or equal to 5.5 years |
| OG008 | QuickSite/QuickFlex Lead Age: Less Than 5 Years | lead age: less than 5 years |
| OG009 | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | lead age: 5 to less than 6 years |
| OG010 | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years | lead age: greater than or equal to 6 years |
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| OG004 |
| Riata Leads Lead Age: 6-less Than 7 Years |
lead age: 6-less than 7 years |
| OG005 | Riata Leads Lead Age: 7 Years or Greater | lead age: 7 years or greater |
| OG006 | Riata ST Lead Age: Less Than 5.5 Years | lead age: less than 5.5 years |
| OG007 | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | lead age: greater than or equal to 5.5 years |
| OG008 | QuickSite/QuickFlex Lead Age: Less Than 5 Years | lead age: less than 5 years |
| OG009 | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | lead age: 5 to less than 6 years |
| OG010 | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years | lead age: greater than or equal to 6 years |
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