Effects of Closed-loop Stimulation vs. DDD Pacing on Prevalence and Timing of Haemodynamic Variations and Clinical Prodromes Induced by Head-up Tilt Test in Patients With Refractory Cardioinhibitory Vasovagal Syncope. The TIRECS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Haemodynamic response during head up tilt test.
研究概览
简要总结
Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.
详细描述
A total of 30 patients with refractory cardioinhibitory vasovagal syncope receiving a Biotronik pacemaker with Closed-loop Stimulation (CLS) algorithm will be enrolled in the study. Two head-up tilt test (HUTT), one during DDD 60/min pacing with CLS algorith turned off (CLS-OFF) and the other during DDD-CLS pacing (CLS-ON), will be performed one week apart; patients will be randomly and blindly assigned to group A (n=15, first HUTT in CLS-ON mode) or B (n=15, first HUTT in CLS-OFF mode). During HUTT heart rate, blood pressure, and the incidence of clinical prodromes and syncope wil be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Refractory cardioinhibitory vasovagal syncope treated with permanent pacemaker;
- •Pacemaker Biotronik with Closed-loop Stimulation algorithm
- •Ability to perform a head up tilt test
- •Completion of the 18th year of age
排除标准
- •Contraindications to head up tilt test
结局指标
主要结局
Haemodynamic response during head up tilt test.
时间窗: 45 minutes
Assessment of the values of systolic blood pressure
Incidence of prodromal symptoms during head up tilt test.
时间窗: 45 minutes
Assessment of patient-reported symptoms during the test
Incidence of syncope during head up tilt test.
时间窗: 45 minutes
Assessment of patient-reported symptoms during the test
次要结局
未报告次要终点
研究者
Pietro Palmisano
physician
Azienda Ospedaliera Cardinale G. Panico