跳至主要内容
临床试验/NCT05278585
NCT05278585招募中不适用

Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI: the PACE-TAVI Registry

AZ Sint-Jan AV12 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
12
主要终点
Positive and negative predictive value of RAP for PPM implantation post TAVI

研究概览

简要总结

The current observational registry aims to evaluate in patients undergoing TAVI implantation:

  1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
  2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
  3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.

详细描述

The persistent growth in transcatheter aortic valve implantation (TAVI) calls for optimized early discharge programs to handle the increasing patient load. While access site bleeding and stroke rate have decreased with improved technologies and operators' experience, acquired conduction abnormalities necessitating prolonged rhythm-monitoring and permanent pacemaker (PPM) implantation have remained largely unchanged, and even up to 39.9% for some TAVI platforms. Prompt identification of patients necessitating PPM implantation leads to optimal patient care and use of resources. Conversely, prompt identification of patients with low -to no- risk for PPM post TAVI shortens their hospitalization and facilitates early and safe discharge.

Several baseline characteristics such as age, preexistent right bundle branch block (RBBB) and the use of self-expanding valves are associated with post-TAVI PPM implantation, but more practical and clinically more relevant parameters are needed with high negative and positive predictive values that could support clinical decision-making.

En passant rapid atrial pacing (RAP) immediately following TAVI has recently been reported to be a valuable tool in PPM risk stratification. The absence of Wenckebach phenomena post implantation at RAP up to 120/' has a negative predictive value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data). This technique improves our clinical assessment and identification of low-risk patients for PPM suitable for safe early discharge, as well as high-risk patients requiring further rhythm monitoring and eventual PPM implantation.

The current observational registry aims to evaluate in patients undergoing TAVI implantation:

  1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
  2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
  3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • All patients in sinus rhythm with TAVI

排除标准

  • Patients in atrial fibrillation at the time of the implantation
  • Patients with pre-existent pacemaker

结局指标

主要结局

Positive and negative predictive value of RAP for PPM implantation post TAVI

时间窗: 1 month after TAVI

Permanent pacemaker implantation

时间窗: 1 month after TAVI

New conduction abnormalities

时间窗: within 1 week after TAVI

次要结局

  • Stroke(1 month after TAVI)
  • Duration of hospitalization(1 month after TAVI)
  • Echocardiographic changes(1 month after TAVI)
  • Major vascular bleeding(1 month after TAVI)
  • New pericardial effusion(1 month after TAVI)
  • All-cause mortality(1 month after TAVI)

研究者

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

Ian Buysschaert, MD PhD

Principal Investigator

AZ Sint-Jan AV

研究点 (12)

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