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临床试验/NCT01801098
NCT01801098已完成不适用

Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis

Klinik für Kardiologie, Pneumologie und Angiologie1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Determination of HV interval

研究概览

简要总结

The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation.

The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.

研究设计

研究类型
Observational
观察模型
Cohort

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

  • symptomatic aortic valve stenosis
  • patients screened for TAVI
  • written informed consent

排除标准

  • unconsciousness, not able to consent
  • < 18 years
  • permanent pacemaker

结局指标

主要结局

Determination of HV interval

时间窗: Changes in Baseline to 24 hours

HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation.

次要结局

  • AV-block development after 1 month, 6 months and 12 months(1 month, 6 months and 12 months)

研究者

发起方
Klinik für Kardiologie, Pneumologie und Angiologie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Director Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

研究点 (1)

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