临床试验/NCT00870324

NCT00870324已完成不适用

OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

Abbott Medical Devices2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2009年3月最近更新: 2019年2月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Abbott Medical Devices
入组人数: 50
试验地点: 2
主要终点: The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA 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

•Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
•Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant

排除标准

•Patients with a history of Permanent or Persistent AF
•Patient's life expectancy is less than 12 months.
•Patient is pregnant.
•Patient's age at enrollment is less than 18 years.

结局指标

主要结局

The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).

时间窗: 3 months post-implant

次要结局

未报告次要终点

研究者

发起方

Abbott Medical Devices

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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