Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients: An Acute Study in Patients Undergoing an Electrophysiology Study or Pacemaker Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change of blood pressure upon initiation of pacing with AV delays of 40 ms
研究概览
简要总结
The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite medical treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has hypertension with systolic blood pressure >140 mmHg despite at least one antihypertensive medication.
- •Patient has a clinical indication for a pacemaker or an electrophysiology study involving introduction of transvenous electrophysiology catheters to the right atrium and/or right ventricle.
- •Patient is willing and able to provide informed consent
排除标准
- •Patient is in atrial fibrillation at the time of the study
- •Patient has an ejection fraction less than 45%
- •Patient has a history of symptomatic heart failure, regardless of EF
- •Patient is undergoing an ablation procedure for a bypass track (WPW)
- •Patient has a history of resuscitation from ventricular fibrillation or sustained ventricular tachycardia
研究组 & 干预措施
Treatment
The study was a single arm, unblinded, treatment only study. Each patient served as his or her own control.
Treatment delivered by a dual chamber pacing system (BackBeat Medical) which was able to generate stimulating patterns with characteristics that are different than the common pacemaker.
The study was limited to hypertensive patients who were also already scheduled to undergo an invasive electrophysiology procedure.
干预措施: A dual chamber pacing system (BackBeat Medical) (Device)
结局指标
主要结局
Change of blood pressure upon initiation of pacing with AV delays of 40 ms
时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay
Change of blood pressure upon initiation of pacing with AV delays of 2 ms
时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay
Change of blood pressure upon initiation of pacing with AV delays of 20 ms
时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay
Change of blood pressure upon initiation of pacing with AV delays of 80 ms
时间窗: Approx. 5 minutes after initiating pacing with the respective AV delay
Assessment of any adverse effects
时间窗: Over a 24 hour period following the acute tests
次要结局
未报告次要终点