Prospective Non-Randomized Comparison of Point-by-Point Cryoablation Using Freezor™ Xtra Versus Radiofrequency Ablation Using TactiFlex™ SE of Parasympathetic Ganglia (Cardioneuroablation) in Patients With Vagally-Mediated Bradyarrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrence of Bradyarrhythmia or Syncope
研究概览
简要总结
Bradyarrhythmias are conditions where the heart beats too slowly, causing symptoms like dizziness, fainting, and fatigue. In some patients, these slow heart rhythms are caused by overactivity of the vagus nerve (the part of the nervous system that slows the heart down).
Cardioneuroablation (CNA) is a catheter-based procedure that targets and reduces the effect of these overactive nerves on the heart. It is an alternative to permanent pacemaker implantation, especially for younger patients.
Traditionally, CNA is performed using radiofrequency (RF) energy to create small burns in specific areas of the heart. This study investigates whether focal cryoablation (freezing technology using the Freezor™ Xtra catheter) is as safe and effective as standard RF ablation for CNA.
This is a prospective, non-randomized study. Participants will receive either RF ablation (N=30) or cryoablation (N=30). The study will evaluate the recurrence of slow heart rhythms and fainting episodes, as well as any complications, over 12 months of follow-up.
详细描述
Background and Rationale
Cardioneuroablation is an emerging treatment for vagally-mediated bradyarrhythmias, including symptomatic sinus bradycardia, atrioventricular blocks, and vasovagal syncope with a cardioinhibitory component . The procedure targets ganglionated plexi located in the epicardial fat and myocardium, which contain parasympathetic nerve endings.
While radiofrequency (RF) energy is the standard modality for CNA, epicardial fat may limit RF lesion formation when fat thickness exceeds 3 mm. Cryoablation, by contrast, uniformly cools tissue without energy dissipation in fat, potentially offering more consistent ganglion ablation.
To date, no clinical study has compared focal cryoablation versus RF ablation specifically for cardioneuroablation.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years;
- •Symptomatic bradycardia (sinus bradycardia or bradycardia due to atrioventricular block, including transient);
- •Severe asymptomatic sinus bradycardia (heart rate less than 30 beats per minute);
- •Transient second- or third-degree atrioventricular block;
- •Persistent second-degree atrioventricular block;
- •Rhythm pauses greater than 6 seconds;
- •Recurrent syncope or presyncope with documented association with bradycardia (without trauma);
- •Positive response to atropine (heart rate increase ≥25% from baseline or >90 beats per minute) OR positive response to exercise (heart rate increase ≥25% from baseline or >90 beats per minute, OR conversion of second- or third-degree atrioventricular block to first-degree block or complete normalization of atrioventricular conduction during sinus rhythm);
排除标准
- •Chronic antiarrhythmic drug therapy (ongoing);
- •Presence of implanted pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator;
- •Bradyarrhythmia secondary to medications;
- •Bradyarrhythmia secondary to electrolyte imbalance (hyperkalemia);
- •Bradyarrhythmia secondary to hypothyroidism;
- •Bradyarrhythmia secondary to obstructive sleep apnea syndrome;
- •Absence of response to pharmacological denervation (no heart rate increase after atropine administration up to maximum dose of 0.2 mg/kg);
- •Clinically significant coronary artery disease;
- •Post-myocardial infarction cardiosclerosis;
- •Hemodynamically significant congenital heart disease (including surgically corrected);
- •Stable ventricular tachycardia in the setting of bradycardia;
- •History of stroke or transient ischemic attack;
- •Prior open-heart surgery;
- •Prior catheter-based coronary artery intervention or percutaneous coronary intervention;
- •Pregnancy or breastfeeding; Age less than 18 years Age greater than 60 years
研究组 & 干预措施
CryoCNA
干预措施: Focal Cryoablation (Procedure)
RF CNA
干预措施: Radiofrequency Catheter Ablation (Procedure)
结局指标
主要结局
Recurrence of Bradyarrhythmia or Syncope
时间窗: 12 months
Documented recurrence of symptomatic bradyarrhythmia (sinus bradycardia \<40 bpm, pause \>3 sec, AV block) or syncope confirmed by ECG or Holter
次要结局
- Pericardial Effusion or Hemopericardium(Periprocedural (7 days))
- Inappropriate Sinus Tachycardia(12 months)
- Vascular Access Complications(Periprocedural (7 days))
- Change in Minimum Heart Rate(Baseline to 6 months)
- Change in Maximum Heart Rate(Baseline to 6 months)
- Change in Electrophysiological Parameters(Intraprocedural)
- Change in Mean Heart Rate(Baseline to 6 months)