Attain StarFix® Model 4195 LV Lead Extraction Study

Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 227 人开始时间: 2009年7月最近更新: 2016年2月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 227
主要终点: Removal success of LV leads implanted for more than 180 days

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.

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

•Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
•Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
•Intention to remove the LV lead prior to the extraction procedure
•Subject is 18 years of age or older
•Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol

排除标准

未提供

结局指标

主要结局

Removal success of LV leads implanted for more than 180 days

时间窗: More than 180 days post-implant

次要结局

Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days(90 -180 days post-implant)
Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool.(0 to 45 days post-lead extraction)
Success of lead removal by how long the lead has been implanted(More than 180 days post-implant)
Summary of tools & techniques used to remove LV leads.(More than 180 days post-implant)

研究者

发起方

Medtronic Cardiac Rhythm and Heart Failure

申办方类型

Industry

责任方

Sponsor

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