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临床试验/NCT06814574
NCT06814574招募中不适用

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience

Deutsches Herzzentrum Muenchen1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Safety

研究概览

简要总结

Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Transcatheter Tricuspid Valve Replacement

排除标准

  • no defined exclusion criteria

结局指标

主要结局

Safety

时间窗: through study completion (an average of 6 Months)

Peri- and postprocedural complications associated with pacemaker implantation after TTVR.

Feasibility

时间窗: at the time of surgery

Successful pacemaker implantation, regardless of the type of pacemaker, in relation to all patients with a relevant indication following TTVR.

Success

时间窗: at the time of surgery

The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.

次要结局

  • Pacemaker Implantation - Procedural Details(at the time of surgery)
  • Type of Pacemaker Implantation(at the time of surgery)
  • Electric Performance(at the time of surgery, through study completion (an average of 6 Months))

研究者

发起方
Deutsches Herzzentrum Muenchen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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