St.Jude Medical Cardiac Lead Assessment Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,216
- 试验地点
- 45
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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
Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)
时间窗: 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.
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.
时间窗: 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
Number of Leads With Electrical Dysfunction
时间窗: 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.
Number of Leads With Externalized Conductors
时间窗: 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
The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
时间窗: 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.
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.
时间窗: 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
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.
时间窗: 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
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
时间窗: 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
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
时间窗: 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
次要结局
- Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant(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 Externalized Conductors to Clinical Intervention, by Year of Initial Implant(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(This outcome is assessed from time of detection of other visual lead anomaly until 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).(within 30 days associated with study lead related interventions)
- Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC)(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).(This outcome is assessed from enrollment 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(This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up)