NCT02324920已完成不适用
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 24
- 主要终点
- Patients With Recurrence of Syncopal Episode
研究概览
简要总结
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 affected by clinical diagnosis of reflex syncope who meet all the following criteria:
- •age >=40 years
- •significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.
- •type 2B cardio-inhibitory response to TT (according to the VASIS classification).
- •Alternative therapies have failed or were not feasible.
- •exclusion of other possible competitive causes of syncope.
排除标准
- •Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines
- •Any cardiac dysfunctions possibly leading to loss of consciousness:
- •overt heart failure;
- •ejection fraction (LVEF) <40% (Echo-assessed within 3-month prior to study participation);
- •myocardial infarction;
- •diagnosis of hypertrophic or dilated cardiomyopathy;
- •clinically significant valvular disease;
- •sinus bradycardia <50 bpm or sinoatrial block;
- •Mobitz I second-degree atrioventricular block;
- •Mobitz II second or third-degree atrioventricular block;
- •bundle-branch block;
- •rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
- •preexcited QRS complexes;
- •prolonged QT interval;
- •Brugada syndrome;
- •arrhythmogenic right ventricular cardiomyopathy
- •Symptomatic orthostatic hypotension diagnosed by standing BP measurement;
- •Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
- •Symptomatic cardioinhibitory carotid sinus hypersensitivity.
结局指标
主要结局
Patients With Recurrence of Syncopal Episode
时间窗: 24 months
次要结局
- Patients With Recurrence of Pre-syncope or Syncope(24 months)
研究者
研究点 (24)
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