跳至主要内容
临床试验/NCT00180401
NCT00180401终止不适用

MODULA-Study: Modul 10: Benefit of CRT-therapy in CRT-Patients With QRS-complex of 120 - 150 ms

Boston Scientific Corporation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
1
主要终点
Observational: Benefit of CRT

研究概览

简要总结

The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms.

详细描述

The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of > 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
  • New York Heart Association (NYHA) III
  • Ejection fraction (EF) below 35%
  • Optimised medical therapy
  • QRS-complex above 120 ms

排除标准

  • Patients with CRT-P and atrial fibrillation

结局指标

主要结局

Observational: Benefit of CRT

时间窗: 12 month

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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