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临床试验/NCT00385749
NCT00385749Unknown不适用

Right Ventricular Defibrillation Lead Select Site Study

Associates in Cardiology, PA2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2006年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
98
试验地点
2
主要终点
Acute defibrillation thresholds

研究概览

简要总结

This study will compare single coil right ventricular defibrillation leads for implanted cardioverter/defibrillators (ICDs) in the apical and high septal locations. It is hypothesized that RV septal positions are at least as good as apical positions using formally measured defibrillation thresholds(DFTs), and that they may have long term advantages in reducing left ventricular dysfunction.

详细描述

The new studies "Right Ventricular Lead/Select Site Registry" and "Right Ventricular Lead/Select Site Registry: Acute Study" are studies designed to look at alternate lead locations for defibrillation leads for ICDs. The registry is designed to capture data from patients who have already undergone implant, so as to be able to publish long term data on defibrillation thresholds, pacing thresholds and left ventricular function. This will include both patients from the acute study, and those patients in whom leads have already been placed, and the exact lead location is known. The acute study is designed to directly compare defibrillation thresholds in the apical location versus the interventricular septal location for defibrillation leads. This study involves a direct comparison of two different sites in the same patient; using defined criteria for implant location (see protocol). The acute study is anticipated to enroll 34 patients, but the registry to collect ongoing data will be larger, encompassing previously implanted patients, with an expected sample size of 61 total in the registry for data collection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Standard indications for ICD placement (AHA/ACC guidelines)

排除标准

  • Inability to consent
  • age less than 21 years
  • inability to participate in study follow-up

结局指标

主要结局

Acute defibrillation thresholds

次要结局

  • LV function (LVEF)
  • pacing thresholds
  • sensing thresholds
  • LV diameter
  • NYHA class
  • weight

研究者

发起方
Associates in Cardiology, PA
申办方类型
Other

研究点 (2)

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