跳至主要内容
临床试验/NCT05077670
NCT05077670进行中(未招募)不适用

Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping

Fundacion para la Innovacion en Biomedicina (FIBMED)1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月1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)
发起方
入组人数
50
试验地点
1
主要终点
CartoFinder and COHERENT tools utility assessment

研究概览

简要总结

The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.

详细描述

The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers.

The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persistent atrial fibrillation
  • The patient has signed the informed consent form
  • No LAA previous ablation procedure
  • No valvular disease
  • LVEF ≥ 35% prior to recruitment
  • Age ≥ 18 years

排除标准

  • LVEF < 35 %
  • Hyperthyroidism or hypothyroidism
  • Mental or physical illness incapacitation
  • Planned cardiac procedure
  • Non-controlled hypertension
  • Terminal renal failure or dialysis
  • Class IV of the NYHA
  • Age ≥ 75 years
  • Life expectancy < 2 years
  • Atrioventricular block
  • Pregnancy

结局指标

主要结局

CartoFinder and COHERENT tools utility assessment

时间窗: 2 years

To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.

次要结局

  • Atrial fibrillation driver location analysis(2 years)

研究者

发起方
Fundacion para la Innovacion en Biomedicina (FIBMED)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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