Endocardial Ablation of Ganglionated Plexi Versus Pacemaker Implantation in Patients With Symptomatic Sinus Node Dysfunction
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in the SF-36 Health Survey of quality of life
研究概览
简要总结
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a component of vagal hypertonia. Nevertheless, there is currently a paucity of literature about the results according to the type of presentation (VV, AVB or SND). The investigators aim to assess the safety and efficacy of cardioneuroablation for the treatment of symptomatic SND.
详细描述
Sinus node dysfunction (SND), also known as sick sinus syndrome, comprises a wide spectrum of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial block, and sinus arrest to bradycardia tachycardia syndrome. An additional manifestation of SND is an inadequate chronotropic response to exercise, reported as chronotropic incompetence. Since the first cardiac denervation was reported in 2005, several registries and retrospective studies using this therapeutic approach for reflex syncope, SND and functional atrioventricular block have been published. However, due to the lack of randomized studies, current guidelines recommend permanent pacemaker implantation for patients with symptomatic SND in order to improve symptoms. Therefore, the purpose of the present study is to assess the safety and efficacy of cardioneuroablation versus permanent pacemaker implantation for the treatment of symptomatic SND.
This is a multicenter, randomized, open, interventional study. After being informed of the study and potential risks, participants will undergo a one week screening period to determine eligibility for the study entry. During this week, participants will undergo an exercise test, atropine test, and a 24 hour-holter electrocardiogram. Then, participants who meet the eligibility criteria, will be randomized 1:1 to receive permanent pacemaker implantation (control group) or cardioneuroablation (interventional group).
The primary endpoint (improve in quality of life assessed with 36-Item Short Form Survey (SF-36)) will be evaluated at six months since randomization.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (<40 bpm) or chronotropic incompetence in the exercise test).
- •Absence of structural cardiopathy
排除标准
- •Left ventricular ejection fraction <50%
- •Severe valvular disease
- •Any type of cardiomyopathy such as hypertrophic cardiomyopathy
- •Previous ischemic heart disease
- •QRS interval >130 ms
- •Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
- •Lifetime expectance <12 months
研究组 & 干预措施
Cardioneuroablation
After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx or Carto system), localization of ganglion plexus (GP) will be performed either anatomically and/or by means of high frequency stimulation (HFS). The anterior and superior right sided GP will always be ablated per protocol. Other GP will be ablated according to interventional electrophysiologist judgement. The endpoint of the ablation procedure will be 1) absence of a vagal response after HFS from the right jugular vein and 2) an increase in at least 10 bpm as compared to baseline.
干预措施: Cardioneuroablation (Procedure)
Permanent pacemaker implantation
A dual chamber pacemaker implantation will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.
干预措施: Permanent dual chamber pacemaker implantation (Device)
结局指标
主要结局
Change from baseline in the SF-36 Health Survey of quality of life
时间窗: Baseline and 6 months
The SF-36 Health Survey is a validated, well known generic test for assessment of the health-related quality of life of patients.
次要结局
- 6 month free survival from permanent pacemaker implantation in the interventional group (cardioneuroablation)(Baseline and 6 months)
- Differences in complications rates between both gropus(Baseline and 6 months)
- Differences in 6 month free survival from syncope between both groups(Baseline and 6 months)
- Change in maximal heart rate and chronotropic incompetence in the exercise test(Baseline and 6 months)
研究者
Carlos Minguito Carazo
Principal Investigator, Cardiology consultant, Electrophysiology fellow
Hospital Clinico Universitario de Santiago