跳至主要内容
临床试验/NCT03535818
NCT03535818进行中(未招募)不适用

Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus

Imperial College London1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
68
试验地点
1
主要终点
Any atrial arrhythmia >30s documented on ECGs

研究概览

简要总结

The investigator propose to test the efficacy of adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF.

详细描述

Patients with ongoing paroxysmal arrhythmias after pulmonary vein isolation (PVI) for paroxysmal and persistent atrial fibrillation (AF) get incrementally less benefit with redo-PVI. This implies non-pulmonary vein (PV) triggers, which are more challenging to locate. The autonomic nervous system is implicated in the multifactorial pathogenesis of AF but few studies have attempted neural targeting as a therapeutic intervention. We have demonstrated that stimulation of specific left atrial ganglionated plexi (GPs) triggers both AF and atrial ectopy and importantly stimulation of these sites may not induce AV block, the 'conventional' marker used to locate GPs. Having shown that these ectopy-triggering GP (ET-GP) sites are anatomically stable and can be rendered inactive by either ablation at the site or by ablation between the site and the adjacent PV, a single centre study suggests that ET-GP ablation can prevent recurrent AF in some patients.

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 (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females eighteen (18) to eighty five (85) years old
  • Paroxysmal atrial fibrillation
  • Previous pulmonary vein isolation
  • Suitable candidate for catheter ablation
  • Signed informed consent

排除标准

  • Contraindication to catheter ablation
  • Presence of a cardiac thrombus
  • Valvular disease that is grade moderate or greater
  • Any form of cardiomyopathy
  • On amiodarone therapy
  • Patients who lack capacity
  • Active gastrointestinal bleeding
  • Active infection or fever
  • Renal failure (Creatinine >200µmol/L)
  • Life expectancy shorter than the duration of the trial
  • Bleeding or clotting disorders or inability to receive heparin

结局指标

主要结局

Any atrial arrhythmia >30s documented on ECGs

时间窗: 12 months

After blanking period 3 months

次要结局

  • Symptom recurrence requiring repeat ablations(12 months)
  • Radiofrequency time(Within ablation procedure)
  • Complications(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验