Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 142
- 试验地点
- 27
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years at time of enrollment consent
- •Subject has a diagnosis of IST
- •Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs
- •Subject is willing and able to provide written informed consent
排除标准
- •Subjects on whom cardiac surgery or single lung ventilation cannot be performed
- •Subjects with indication for or existing ICDs/Pacemakers
- •Presence of channelopathies
- •Previous cardio-thoracic surgery
- •Left Ventricular Ejection Fraction (LVEF) < 50%
- •Body Mass Index (BMI) ≥ 35
- •Presence of supraventricular or ventricular tachycardia
- •Presence of Postural Orthostatic Sinus Tachycardia (POTS)
- •Presence of congenital heart disease
- •History suggestive of secondary cause of tachycardia such as pheochromocytoma, anemia, thyrotoxicosis, chronic fever of unknown origin, COPD, long-term bronchodilators use, severe asthma or carcinoid syndrome
- •Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
- •Life expectancy < 24 months
- •Pregnant or planning to become pregnant during trial
- •Subjects with substance abuse
- •Subjects with previous weight loss surgery
- •Subject is unwilling and/or unable to return for scheduled follow-up visits
- •Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a trial that may interfere with trial results
- •Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
研究组 & 干预措施
Hybrid sinus node sparing ablation procedure
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
干预措施: AtriCure ISOLATOR Synergy Surgical Ablation System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 12-months Post Procedure
Freedom from IST at 12-months. Freedom from IST is defined as mean heart rate of ≤ 90bpm or at least a 15% reduction in mean heart rate as compared to baseline, in the absence of new or higher dosage of previously failed medications.
Primary Safety Endpoint
时间窗: 30-days Post Procedure
Incidence of device or procedure-related major adverse events (MAEs) for subjects undergoing the hybrid sinus node sparing ablation procedure from the index procedure through 30-days post procedure
次要结局
- Reduction in mean heart rate in the absence of rate control drugs(24-months Post Procedure)
- Improved heart rate variability - 7-day monitor(12-months Post Procedure)
- 6-Minute Walk Test(24-months Post Procedure)
- Self-Rating Anxiety Scale(24-months Post Procedure)
- Mean heart rate(24-months Post Procedure)
- Reduction in mean heart rate regardless of rate control drugs(24-months Post Procedure)
- Health Economics(24-months Post Procedure)
- QoL - SF-12(24-months Post Procedure)
- Device or procedure related Serious Adverse Events(12-months Post Procedure)
- Borg dyspnea score(24-months Post Procedure)
- IST symptom reduction(24-months Post Procedure)
- Improved heart rate variability - Implantable loop recorder(12-months Post Procedure)