Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Syncope
研究概览
简要总结
The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.
详细描述
The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation. Major inclusion criteria for enrollment are history of VVS or symptomatic bradyarrhythmia, age < 60 years, and evaluation by a physician and discussion about potential candidacy for radiofrequency cardioneuroablation or permanent pacemaker implantation for medically refractory symptoms.
For analysis purposes, patients awaiting the intervention will remain in the "control group" and will cross-over to the "procedural group" after successful completion of radiofrequency cardioneuroablation procedure. The follow-up for the procedure group will start at completion of CNA procedure, but patients who eventually do not get the procedure will stay in the control group until the end of the study, with similar follow-up performed as for the patients undergoing RFCA procedure. If a patient in the control group undergoes permanent pacemaker placement, then the day after the procedure the patient will be removed from the control group for follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures
- •age < 60 years
排除标准
- •age > 60 years
- •intra-/infra-Hisian AV block
- •intrinsic sinus node disease
- •history of supraventricular tachycardia
- •history of ventricular tachycardia
- •presence of structural heart disease related
- •prior history of catheter ablation
- •presence of inheritable arrhythmic conditions
- •orthostatic hypotension on HUTT test
- •abnormal thyroid function levels
- •Proven indication for permanent pacemaker implantation
结局指标
主要结局
Syncope
时间窗: 3 years
Recurrent syncope
次要结局
- Presyncope burden(3 years)
- Quality of life before and 12 months after ablation(1 year)
- Syncope burden(3 years)
- Time to first syncopal recurrence(3 years)
- Ablation induced change in heart rate(1 year)
- Complications associated with GP ablation(1 year)
- Redo-ablation procedures(3 years)
- Atrial arrhythmias(3 years)
