NCT01325480终止不适用
High Septal Pacing for Cardiac Resynchronization Therapy Acute Research Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
The purpose of this acute study is to perform a preliminary investigation of high septal right ventricular pacing in the vicinity of the His bundle region as an alternate or adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.
详细描述
The HISTORY Study is an acute, cross-sectional, multi-center, feasibility study with a randomized within patient test sequence designed to characterize the effects of high septal right ventricular pacing in the vicinity of the His bundle region compared to conventional biventricular pacing for cardiac resynchronization therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years of age or older
- •Patients willing and capable of providing informed consent, participating in all testing associated with this clinical investigation
- •Patients undergoing a CRT implant procedure (pacemaker or defibrillator) for one of the following reasons
- •Indicated for a new device
- •Device upgrade
- •Device replacement
- •Lead revision
- •Note: recognized indications for CRT-P and CRT-D as of October 2009 are valid for inclusion in this study. Should new indications become approved during the study conduct; those will also be applied within the inclusion criteria.
排除标准
- •Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent
- •Patients in AF that cannot be cardioverted for the study
- •RBBB pattern
- •Sustained, uncontrolled ventricular tachycardia
- •Sinus rhythm < 30 bpm or >100 bpm
- •Complete AV node block
- •Second degree AV block
- •Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion);
- •History of (hemorrhagic) cerebro-vascular accident or TIA
研究者
研究点 (1)
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