An observational study in Externalized Conductors, Visual Lead Anomalies and Electrical Dysfunction, sponsored by Abbott Medical Devices. Completed at 45 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Abbott Medical Devices · Observational
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.
Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patient has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted
Device: Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads
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
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: This outcome is assessed from year 2 to year 3 follow-up
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
Time frame: This outcome is assessed from time of detecting EC till the course of 3 years of 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: This outcome is assessed from enrollment till the course of 3 years of follow-up
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.
| Milestone | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| Started | 982 | 670 | 458 | 737 |
| Completed | 618 | 335 | 252 | 480 |
| Not completed | 364 | 335 | 206 | 257 |
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.
| implanted leads | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| Number of Leads With Electrical Dysfunction | 24 | 27 | 15 | 2 |
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
| implanted leads | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| Number of Leads With Externalized Conductors | 0 | 144 | 44 | 10 |
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.
| implanted leads | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities) | 7 | 19 | 7 | 4 |
Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.
| leads with electrical dysfunction/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads. | 0.010 | 0.019 | 0.014 | 0.001 |
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
| leads with externalized conductors/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| 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. | 0.0025 (0.0003 to 0.0089) | 0.0480 (.0287 to 0.0748) | 0.0158 (0.0052 to 0.0365) | 0.0288 (0.0165 to 0.0463) |
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
| leads with externalized conductors/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| 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. | 0.0015 (0 to 0.0081) | 0.0897 (0.0599 to 0.1278) | 0.0234 (0.0086 to 0.0503) | 0.0087 (0.0024 to 0.022) |
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
| leads with externalized conductors/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| 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. | 0.0035 (0.0004 to 0.0126) | 0.0658 (0.0373 to 0.1062) | 0.0097 (0.0012 to 0.0346) | 0.0110 (0.003 to 0.0280) |
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
| leads w other visual lead anomaly/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| 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 | 0.0025 (0.0003 to 0.0090) | 0.0108 (0.0035 to 0.0251) | 0.0117 (0.0032 to 0.0296) | 0.0053 (0.0011 to 0.0153) |
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
| leads w other visual lead anomaly/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| 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 | 0 (0 to 0.0054) | 0.0027 (0.0001 to 0.0148) | 0.0070 (0.0008 to 0.025) | 0.0021 (0.0001 to 0.0115) |
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
| leads w other visual lead anomaly/years | Durata Leads | Riata Leads | Riata ST | QuickSite/QuickFlex |
|---|---|---|---|---|
| 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 | 0 (0 to 0.0065) | 0.0066 (0.0008 to 0.0235) | 0 (0 to 0.0160) | 0 (0 to 0.0095) |
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
| lead anomaly events | Durata Leads Lead Age: Less Than 4 Years | Durata Leads Lead Age: 4 to Less Than 5 Years | Durata Leads Lead Age: 5 Years or Greater | Riata Leads Lead Age: Less Than 6 Years | Riata Leads Lead Age: 6-less Than 7 Years | Riata Leads Lead Age: 7 Years or Greater | Riata ST Lead Age: Less Than 5.5 Years | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | QuickSite/QuickFlex Lead Age: Less Than 5 Years | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years |
|---|---|---|---|---|---|---|---|---|---|---|---|
| year 0 from detecting externalized conductor | 0 | 0 | 0 | 1 | 1 | 3 | 0 | 1 | 0 | 0 | 0 |
| year 1 from detecting externalized conductor | 0 | NA | NA | 2 | 1 | 5 | 0 | 2 | 0 | 0 | 0 |
| year 2 from detecting externalized conductor | NA | NA | NA | 2 | 2 | 6 | 1 | 2 | 0 | 0 | 0 |
| year 3 from detecting externalized conductor | NA | NA | NA | 2 | 3 | 6 | 1 | 4 | NA | 0 | 0 |
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
| lead anomaly events | Durata Leads Lead Age: Less Than 4 Years | Durata Leads Lead Age: 4 to Less Than 5 Years | Durata Leads Lead Age: 5 Years or Greater | Riata Leads Lead Age: Less Than 6 Years | Riata Leads Lead Age: 6-less Than 7 Years | Riata Leads Lead Age: 7 Years or Greater | Riata ST Lead Age: Less Than 5.5 Years | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | QuickSite/QuickFlex Lead Age: Less Than 5 Years | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 years follow up from detecting other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1 years follow up from detecting other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 years follow up from detecting other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 3 years follow up from detecting other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group
| Participants | Durata Leads | Riata Leads | Riata ST Leads | QuickSite/QuickFlex Leads |
|---|---|---|---|---|
| Lead dislodgement or migration | 1 | 0 | 0 | 0 |
| lead insulation damage | 0 | 0 | 0 | 1 |
| phrenic nerve/diaphragmatic stimulation | 0 | 0 | 0 | 1 |
time from externalized conductors to clinical intervention for all lead subgroups.
| lead anomaly events | Durata Leads Lead Age: Less Than 4 Years | Durata Leads Lead Age: 4 to Less Than 5 Years | Durata Leads Lead Age: 5 Years or Greater | Riata Leads Lead Age: Less Than 6 Years | Riata Leads Lead Age: 6-less Than 7 Years | Riata Leads Lead Age: 7 Years or Greater | Riata ST Lead Age: Less Than 5.5 Years | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | QuickSite/QuickFlex Lead Age: Less Than 5 Years | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 years from detecting EC | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 1 year from detecting EC | 0 | 1 | 1 | 2 | 5 | 11 | 3 | 4 | 0 | 0 | 0 |
| 2 years from detecting EC | NA | 1 | 1 | 3 | 7 | 15 | 6 | 4 | 1 | 0 | 0 |
| 3 years from detecting EC | NA | 1 | 1 | 4 | 8 | 18 | 6 | 6 | 1 | 0 | 0 |
Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention
| lead anomaly events | Durata Leads Lead Age: Less Than 4 Years | Durata Leads Lead Age: 4 to Less Than 5 Years | Durata Leads Lead Age: 5 Years or Greater | Riata Leads Lead Age: Less Than 6 Years | Riata Leads Lead Age: 6-less Than 7 Years | Riata Leads Lead Age: 7 Years or Greater | Riata ST Lead Age: Less Than 5.5 Years | Riata ST Leads Lead Age: Greater Than or Equal to 5.5 Years | QuickSite/QuickFlex Lead Age: Less Than 5 Years | QuickSite/QuickFlex Leads Lead Age: 5 to Less Than 6 Years | QuickSite/QuickFlex Leads Lead Age: Greater Than or Equal to 6 Years |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 years from detection other visual lead anomaly | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1 years from detection other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 2 years from detection other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
| 3 years from detection other visual lead anomaly | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
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.
| Participants | With Externalized Conductors (EC) | Without Externalized Conductors (EC) |
|---|---|---|
| 7F lead size (Riata ST) | 57 | 395 |
| 8F lead size (Riata) | 204 | 456 |
Comparison of patients with ED to those without ED: subject age effect on ED
| years | With Electrical Dysfunction (ED) | Without Electrical Dysfunction (ED) |
|---|---|---|
| Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED). | 61.8 ± 13.4 | 67.2 ± 11.9 |
Collected over From enrollment to 3 years of follow-up period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Durata Leads | 130/982 (13.2%) | 26/982 (2.6%) | 20/982 (2%) |
| Riata Leads | 111/670 (16.6%) | 28/670 (4.2%) | 14/670 (2.1%) |
| Riata ST Leads | 64/458 (14%) | 22/458 (4.8%) | 9/458 (2%) |
| QuickSite/QuickFlex Leads | 135/737 (18.3%) | 7/737 (0.9%) | 11/737 (1.5%) |
| Event | Durata Leads | Riata Leads | Riata ST Leads | QuickSite/QuickFlex Leads |
|---|---|---|---|---|
| lead noiseProduct Issues | 4/982 | 8/670 | 8/458 | 0/737 |
| Abnormal high voltage lead impredanceProduct Issues | 3/982 | 5/670 | 5/458 | 0/737 |
| lead insulation damageProduct Issues | 2/982 | 1/670 | 4/458 | 1/737 |
| oversensingProduct Issues | 3/982 | 3/670 | 4/458 | 0/737 |
| Abnormal Pacing ImpedanceProduct Issues | 8/982 | 2/670 | 0/458 | 0/737 |
| Elevated pacing thresholdsProduct Issues | 0/982 | 4/670 | 1/458 | 2/737 |
| lead fractureProduct Issues | 4/982 | 2/670 | 0/458 | 0/737 |
| Lead dislodgement or migrationProduct Issues | 1/982 | 0/670 | 0/458 | 2/737 |
| phrenic nerve/diaphragmatic stimulationProduct Issues | 0/982 | 0/670 | 0/458 | 2/737 |
| Externalized ConductorProduct Issues | 0/982 | 1/670 | 0/458 | 0/737 |
| Event | Durata Leads | Riata Leads | Riata ST Leads | QuickSite/QuickFlex Leads |
|---|---|---|---|---|
| OversensingProduct Issues | 4/982 | 2/670 | 3/458 | 0/737 |
| Phrenic Nerve/Diaphragmatic StimulationProduct Issues | 0/982 | 0/670 | 0/458 | 4/737 |
| Abnormal Pacing ImpedanceProduct Issues | 5/982 | 1/670 | 0/458 | 3/737 |
| Therapy for Non-Ventricular RhythmProduct Issues | 1/982 | 3/670 | 1/458 | 0/737 |
| Lead NoiseProduct Issues | 4/982 | 1/670 | 2/458 | 0/737 |
| Elevated pacing thresholdsProduct Issues | 3/982 | 2/670 | 1/458 | 2/737 |
| Abnormal High Voltage Lead ImpedanceProduct Issues | 2/982 | 2/670 | 0/458 | 0/737 |
| Other Visual Lead AnomaliesProduct Issues | 0/982 | 0/670 | 1/458 | 0/737 |
| Oversensing Resulting in TherapyProduct Issues | 0/982 | 0/670 | 1/458 | 0/737 |
| Lead Insulation DamageProduct Issues | 0/982 | 1/670 | 0/458 | 0/737 |
The study enrolled a total of 2,216 study participants
| Age, Continuous(years) | All Subjects Enrolled in the Study |
|---|---|
| Mean | 67 ± 12 |
| Sex: Female, Male(Participants) | All Subjects Enrolled in the Study |
|---|---|
| Female | 600 |
| Male | 1616 |
| Ethnicity (NIH/OMB)(Participants) | All Subjects Enrolled in the Study |
|---|---|
| Hispanic or Latino | 56 |
| Not Hispanic or Latino | 2158 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | All Subjects Enrolled in the Study |
|---|---|
| American Indian or Alaska Native | 8 |
| Asian | 91 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 335 |
| White | 1770 |
| More than one race | 0 |
| Unknown or Not Reported | 9 |
| Region of Enrollment(participants) | All Subjects Enrolled in the Study |
|---|---|
| Canada | 48 |
| United States | 2085 |
| Japan | 83 |
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