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临床试验/NCT01179997
NCT01179997已完成3 期

Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2010年8月11日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
156
试验地点
1
主要终点
6-month echocardiographic response

研究概览

简要总结

The aim of this study was to compare the response to cardiac resynchronization therapy when the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to response when it was optimized following QRS width criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.

排除标准

  • 未提供

研究组 & 干预措施

Tissue Doppler Imaging (TDI) optimization

Active Comparator

Interventricular pacing delay optimized according to Tissue-Doppler echocardiography

干预措施: Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves (Device)

Electrocardiographic optimization

Active Comparator

Interventricular pacing delay optimized according to QRS width observation in the 12-lead surface electrocardiogram

干预措施: Electrocardiographic optimization of the interventricular pacing delay according to QRS width (Device)

结局指标

主要结局

6-month echocardiographic response

Reduction of the end-systolic volume (measured in mililiters according to transthoracic echocardiography) of \>10% as compared to the baseline value.

次要结局

  • 6-month clinical response

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Lluis Mont Girbau

MD PhD

Hospital Clinic of Barcelona

研究点 (1)

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