St.Jude Medical Cardiac Lead Assessment Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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St.Jude Medical Cardiac Lead Assessment Study

Conditions
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Externalized Conductors, Visual Lead Anomalies, Electrical Dysfunction

Intervention / Treatment
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* Device: Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with SJM leads implanted<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Externalized Conductors, visual lead an