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Completed

NCT Number: NCT01507987

St.Jude Medical Cardiac Lead Assessment Study

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).

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Key information

Conditions

Externalized Conductors Electrical Dysfunction Visual Lead Anomalies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

QE II Health Sciences, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
  • Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
  • Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
  • Are 18 years or above

Exclusion criteria

  • Patient is currently pregnant.
  • Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study

Treatment and study plan

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

Primary outcomes

  1. Number of Leads With Electrical Dysfunction

    Time frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up

    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.

  2. Number of Leads With Externalized Conductors

    Time frame: This outcome is assessed at enrollment

    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

  3. Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)

    Time frame: This outcome is assessed at enrollment

    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.

  4. The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.

    Time frame: This outcome is assessed from enrollment through the course of 3 years of follow-up

    Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.

  5. 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.

    Time frame: year 1 follow-up

    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

  6. 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.

    Time frame: year 1 to year 2 follow-up

    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

  7. 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.

    Time frame: year 2 to year 3 follow-up

    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

  8. 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

    Time frame: This outcome is assessed from enrollment to year 1

    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

  9. 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

    Time frame: This outcome is assessed from year 1 to year 2 of follow-up

    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

  10. 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

    Time frame: This outcome is assessed from year 2 to year 3 follow-up

    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

Secondary outcomes

  1. Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant

    Time frame: This outcome is assessed from time of detecting EC till the course of 3 years of follow-up

    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

  2. Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant

    Time frame: This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up

    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

  3. Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other).

    Time frame: within 30 days associated with study lead related interventions

    Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group

  4. Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant

    Time frame: This outcome is assessed from time of detection of externalized conductor to 3 years follow-up

    time from externalized conductors to clinical intervention for all lead subgroups.

  5. Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant

    Time frame: This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up

    Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention

  6. Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC)

    Time frame: This outcome is assessed from enrollment till the course of 3 years of follow-up

    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.

  7. Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED).

    Time frame: This outcome is assessed from enrollment till the course of 3 years of follow-up

    Comparison of patients with ED to those without ED: subject age effect on ED

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: CLAS

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2012
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.