NCT01621464Unknown4 期
Closed Loop Stimulation for Neuromediated Syncope
Spanish Society of Cardiology2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Reduction of number of syncopes
研究概览
简要总结
Physiological stimulation therapy effectiveness will be proved with contractility sensor or CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from neuromediated syncope. Furthermore, not only will be investigated if this system eradicates syncopes, but also if the number of presyncopal episodes is reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that fulfill the requirements of the study:
- •Patients with 5 previous neuromediated syncopes
- •Positive Tilt test, Cardioinhibitory response, heart rate < 40 bpm for at least 10'' or pauses > 3''
- •Patient ≥ 40 years
- •No cardiopathy present
- •Patients without the following contraindications:
- •Drug treatment with β-blockers
- •Chronic Polyneuropathy
- •All contraindications for DDD or DDDR pacing (as per clinical guidelines SEC, 2002)
- •Geographically stable patients and able to attend all follow ups
- •Patients that have signed the informed consent
排除标准
- •Patients that do NOT fulfill the inclusion criteria mentioned above
- •Patients with the contraindications indicated above
- •Patients with syncopes due to Carotid Sinus Hypersensitivity
- •Other syncope causes different to the CNS
- •Patients involved in other clinical studies
- •Pregnant women or in age bearing that are not using at least 2 contraception methods
结局指标
主要结局
Reduction of number of syncopes
时间窗: 1 year
Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope
次要结局
- Time reduction to the first syncope(1 year)
- Reduction of the recurrence of presyncopal symptoms(1 year)
- Improvement of Quality of Life(1 year)
研究者
Gonzalo Barón-Esquivias, MD, PhD, FESC
member of Syncope Working Group (within Section of Electrophysiology and Arrhythmias)
Spanish Society of Cardiology
研究点 (2)
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