Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Improvement in:symptoms(palpitations);quality of life;resting heart rate;mean 24 hour heart rate;heart rate variability;
研究概览
简要总结
Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation at the junction of the superior vena cava and the right atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation.
详细描述
Inappropriate sinus tachycardia syndrome describes a condition in which a patient's heart rate is intermittently (or persistently) higher than expected for the physiological circumstances, with ECG appearance indistinguishable from normal sinus rhythm, after the exclusion of medical conditions causing sinus tachycardia.
Hypothesis- Radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation at the junction of the superior vena cava and the right atrium, will effectively reduce sinus rate acutely and will reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 and 80 years old, who are scheduled for an ablation procedure for suspected inappropriate sinus tachycardia, with symptomatic palpitations during periods where documented electrogram recordings suggest sinus tachycardia (holter, event recorder, or 12 lead ECG).
- •Sinus rate greater than 100 bpm with minimal physiologic challenge, or mean sinus rate during 24 hour holter more than 95bpm, or daytime resting heart rate more than 95bpm.
- •Symptoms (or sinus rate) not explained by an alternative medical or electrophysiological diagnosis.
- •Symptoms refractory to treatment with beta-blocker medication, or beta-blockers contra-indicated or not tolerated
排除标准
- •Children under 18 years of age (due to greater risk from exposure to X rays).
- •Any medical condition significantly increasing the risk of extending the ablation procedure or of X ray exposure, including pregnancy.
- •Significant orthostatic hypotension (due to need for rapid chronotropic response to fall in blood pressure)
- •An alternative cause for sinus tachycardia identified (e.g. hyperthyroidism or pheochromocytoma).
- •Inability or unwillingness to provide informed consent.
结局指标
主要结局
Improvement in:symptoms(palpitations);quality of life;resting heart rate;mean 24 hour heart rate;heart rate variability;
时间窗: Clinical efficacy is established if the improvement is maintained after 6months to a year.
次要结局
- duration of symptom limited Bruce protocol exercise treadmill test;duration of exercise test required to increase rate by 20%.(6 months to 1 year)