跳至主要内容
临床试验/NCT04095559
NCT04095559已完成不适用

Characterization of Left Atrial Substrate by Comparison of Bipolar Voltage Maps With Standard Focal 4.5 mm Tip Electrode, 1 mm Ring Electrode, and Microelectrode Catheters Using InTEllaMap Orion and IntellaNav MIFI O

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Global bipolar and unipolar signal measured in millivolt (mV)

研究概览

简要总结

This study is to investigate the correlation and to obtain the coefficient of correlation between the global and local bipolar signals (voltage maps) of the LA in sinus rhythm using a focal 4.5 mm irrigated-tip ablation catheter (in combination with microelectrodes), a ring-electrode circular mapping catheter and a microelectrode multipolar catheter in combination with the Rhythmia system.

详细描述

Current hypothesis of the mechanism of atrial fibrillation (AF) is a combination of local firing mainly triggered from the pulmonary veins and atrial substrate due to atrial remodelling sustaining AF. Whereas for paroxysmal AF, pulmonary vein isolation (PVI) is still the mainstay of interventional treatment, a left atrial (LA) substrate-based ablation especially in patients with persistent or long-standing persistent AF may be reasonable to improve freedom from AF. In addition, even in patients with paroxysmal AF, substrate-based ablation strategies have been shown to improve outcome. Substrate characterization of the LA is currently performed using the focal ablation catheter with a 3.5mm irrigated tip catheter with a 2 mm interelectrode spacing, a circular (Lasso) or spider like diagnostic (Pentaray) catheter with 1 mm size of the ring electrodes and 2 mm to 4 mm interelectrode spacing. Consequently, the cut-off values to delineate healthy tissue from diseased substrate are defined based on these measures. Since the electrode size and distance between the electrodes determines the bipolar voltage amplitude and morphology (beside their orientation with regard to the propagation wavefront), differences in bipolar voltage values must be expected between different catheter types and especially for the novel micro-electrode catheters IntellaMap Orion and IntellaNav MIFI OI. With the knowledge of the relationship between the bipolar voltage maps created with the different catheter types, information/knowledge from one study obtained with a specific catheter can be transferred to patients treated with the other catheter types. This study is to investigate the correlation and to obtain the coefficient of correlation between the global and local bipolar signals (voltage maps) of the LA in sinus rhythm using a focal 4.5 mm irrigated-tip ablation catheter (in combination with microelectrodes), a ring-electrode circular mapping catheter and a microelectrode multipolar catheter in combination with the Rhythmia system.

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

  • Documented atrial fibrillation
  • First or repeat catheter ablation

排除标准

  • Previous heart surgery (high probability for atypical atrial tachycardia and non PV triggers for AF)
  • Congenital heart disease (corrected or uncorrected)
  • Severe uncorrected valvular heart disease
  • Not willing or qualified for Magnetic Resonance Imaging of the heart
  • Unable to provide informed consent
  • Pregnancy (Pregnancy test will be performed before study participation)
  • Patients with pacemaker or intracardiac defibrillator implanted

结局指标

主要结局

Global bipolar and unipolar signal measured in millivolt (mV)

时间窗: single time point assessment at baseline

Global bipolar and unipolar signal for the different types of catheters measured in mV

Local bipolar and unipolar signal measured in mV

时间窗: single time point assessment at baseline

Local bipolar and unipolar signal for the different types of catheters measured in mV

次要结局

  • Differences of bipolar voltage characteristics between nearfield and farfield signals: Duration in milliseconds (ms)(single time point assessment at baseline)
  • Global fibrosis content and distribution from LGE-MRI measured in [%].(single time point assessment at baseline)
  • Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV)(single time point assessment at baseline)
  • Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency in Hertz (Hz)(single time point assessment at baseline)
  • Local fibrosis content and distribution from Late-gadolinium enhanced Magnetic Resonance Imaging (LGE-MRI) measured in [%].(single time point assessment at baseline)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验