跳至主要内容
临床试验/NCT04642976
NCT04642976已完成不适用

Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.

研究概览

简要总结

Despite progress made in treating atrial fibrillation with catheter ablation, outcomes remain suboptimal with pulmonary vein isolation alone. Ablation of ganglionated plexi (GP) has been shown to be beneficial in patients with atrial fibrillation although optimal strategies of localization of these regions have yet to be determined. The investigators aim to develop a novel strategy of CT guided GP localization to guide ablation in patients with atrial fibrillation. The investigators also aim to clarify the network of innervation between GP to clarify the optimal ablation strategy. This is an observational, single-center study evaluating feasibility and efficacy of CT and high frequency stimulation (HFS) guided GP mapping and ablation in patients with AF undergoing catheter ablation with pulmonary vein isolation. Patients will undergo HFS and CT guided mapping of GPs followed by allocation into one of 8 different GP ablation approaches in a non-randomized fashion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 years
  • History of AF with plan to undergo catheter ablation

排除标准

  • Contraindication or unwillingness to undergo CT imaging or catheter ablation.
  • Pregnancy or lactation

结局指标

主要结局

Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.

时间窗: During Procedure

Number of patients with HFS response identified within 3 pixels (0.625x3=1.875mm) of a location where CT identified epicardial adipose tissue.

次要结局

  • HFS (High Frequency Stimulation) Response Elimination(during procedure)
  • Global Vagal Response Elimination(This will be assessed during the procedure.)
  • Ablation Site Changes - Amplitude of Signals(This will be assessed during the procedure.)
  • Ablation Site Changes - Duration of Signals(This will be assessed during the procedure.)
  • Ablation Site Changes - Fractionation of Signals(This will be assessed during the procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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