Strategy to ROTAblate and PACE (ROTA-PACE) Study
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
- 否
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
Bilal Iqbal
Doctor
Vancouver Island Health Authority
