跳至主要内容
临床试验/NCT06166277
NCT06166277招募中不适用

Cardioneuroablation for the Management of Patients With Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias: The CNA-FWRD Registry

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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