跳至主要内容
临床试验/NCT05404204
NCT05404204Unknown不适用

Strategy to ROTAblate and PACE (ROTA-PACE) Study

Vancouver Island Health Authority1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Successful ventricular pacing

研究概览

简要总结

Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90 years
  • Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.
  • Calcific coronary disease requiring rotational atherectomy

排除标准

  • Pre-existing pacemaker or implantable cardioverter defibrillator.
  • Mobitz II heart block or complete heart block.

结局指标

主要结局

Successful ventricular pacing

时间窗: At the start of the PCI procedure immediately prior to rotational atherectomy

Ability to obtain successful ventricular capture prior to rotational atherectomy

Ventricular pacing threshold

时间窗: At the start of the PCI procedure immediately prior to rotational atherectomy

The pacing threshold to obtain successful ventricular capture

次要结局

  • Complications(At the end of the PCI procedure)

研究者

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

Bilal Iqbal

Doctor

Vancouver Island Health Authority

研究点 (1)

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