Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Implantation of a permanent cardiac pacemaker
研究概览
简要总结
This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation
详细描述
Catheter ablation is a common treatment for cardiac arrhythmias. Some patients with AF ablation or AVNRT experience acceleration of sinus rhythm, the most likely cause of which is modification of autonomic tone caused by inadvertent damage to intramural autonomic ganglia and fibers. Intentional damage to these plexuses has become known as cardioneuroablation (CNA) and is currently used in patients with tachycardia-bradycardia syndrome, vegetatively caused sinus node dysfunction and atrioventricular conduction disorders, vasovagal syncopal conditions developing in a cardioinhibitory type.
It is suggested that in some patients CNA may become an alternative to permanent pacemaker for the treatment of symptomatic bradyarrhythmias.
This is a multicentre randomised clinical study evaluating the efficacy of cardioneuroablation for severe bradycardia due to sinus node dysfunction and/or atrioventricular nide dysfunction versus a sham procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any of the following variants of bradyarrhythmia in patients aged 18-65 years:
- •(1.1.) Symptomatic sinus bradycardia or bradycardia due to atrioventricular blockade, including transient.
- •(1.2.) Severe asymptomatic sinus bradycardia with a rhythm frequency of <30 beats/min.
- •(1.3.) Transient atrioventricular block of II-III degree or permanent block of II degree.
- •(1.4.) Repeated fainting or pre-fainting states with a proven association with bradycardia (without injury).
- •(1.5.) Rhythm pauses >6 seconds.
- •In combination with the following two criteria:
- •Positive reaction to physical activity and/or atropine test:
- •(2.1.) Increase in sinus rhythm frequency ≥25% or >90 beats/min. (2.2.) The transition of atrioventricular blockade of the II-III degree to the 1st degree or complete normalization of atrioventricular conduction at the sinus rhythm.
- •Sinus rhythm at the time of switching on
排除标准
- •Anamnesis of injury during syncopation due to bradycardia, except in the case when the patient refused to implant an electrocardiostimulator for his own reasons in writing;
- •Constant intake of antiarrhythmic drugs (for PVC, AF, etc.);
- •The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator;
- •Drug-induced sinus bradycardia and/or atrioventricular block;
- •Bradycardia due to electrolyte imbalance (e.g. hyperkalemia);
- •Bradycardia due to hypothyroidism or other reversible conditions;
- •No reaction to the administration of atropine (up to a maximum dose of 0.2 mg / kg);
- •Proven association of bradyarrhythmia with episodes of apnea/hypopnea in obstructive sleep apnea syndrome;
- •Clinically significant coronary artery disease;
- •Postinfarction cardiosclerosis;
- •Hemodynamically significant congenital heart defects, including operated ones;
- •Stroke or transient ischemic attack <3 months;
- •Open heart surgery in the anamnesis;
- •Catheter interventions on coronary arteries or for cardiac arrhythmias <3 days;
- •Conditions after percutaneous coronary angioplasty <3 months;
- •Anamnesis of stable ventricular tachycardia on the background of bradycardia;
- •Pregnancy or breastfeeding period
研究组 & 干预措施
Sham group
In the control (sham) group, endocardial electrophysiological study will be performed, but patients will not know which procedure they performed (they are "blinded" in relation to the distribution group). The monitoring will be performed according to the same protocol as in the cardioneuroablation group. In case of recurrence of symptomatic bradycardia and/or (with) syncopal condition without traumatization of the patient in the control group, a transition to the cardioneuroablation group (cross-over) will be proposed. In case of disagreement, a pacemaker is implanted.
干预措施: Electrophysiological study (Diagnostic Test)
Cardioneuroablation
Radiofrequency catheter transmyocardial ablation of the ganglion plexuses (GP) of the atria - cardioneuroablation. The procedure is performed under local anesthesia using intracardiac catheters. Radiofrequency applications will be applied to the endocardial surface of the left and/or right atria in places of typical localization of the densest GPs network in order to destroy nerve fibers and ganglia: in patients with sinus bradycardia - in the left and right atria (5 places with the highest concentration of ganglia); in patients with impaired atrioventricular conduction - in the right atrium and in the left atrium (1 place in the right atrium - at the ostium of the coronary sinus; 2 places in the left atrium - opposite the ostium of the coronary sinus and opposite the Marshall ligament/vein).
干预措施: Ganglionated plexi ablation (Procedure)
结局指标
主要结局
Implantation of a permanent cardiac pacemaker
时间窗: 12 months post procedure
Once there is a recurrence of documented symptomatic bradycardia, a permanent pacemaker implantation is considered
次要结局
- Complications of cardioneuroablation(30 days post procedure)
- Presence of symptomatic or asymptomatic rhythm pauses >6 seconds(12 months post procedure)
- Implantation of a pacemaker by 24 months after randomization(24 months post procedure)
- The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime(12 months post procedure)
- Sinus tachycardia after cardioneuroablation(30 days post procedure)
- Transient or permanent atrioventricular block(12 months post procedure)
- Orthostatic hypotension and/or bradycardia during passive orthostasis test(12 months post procedure)