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临床试验/NCT05366530
NCT05366530终止不适用

IdeNtification of SPecific EleCTrophenotypes in Atrial Fibrillation

Imperial College London1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Freedom From Atrial Fibrillation

研究概览

简要总结

This study will investigate a common heart rhythm disturbance (arrhythmia), atrial fibrillation (AF), to improve understanding of how best to treat it in different patients. Direct current cardioversion (DCCV) is a procedure that can revert the heart to a normal rhythm, however almost all patients will only have a transient benefit, and their heart will return to the abnormal rhythm, AF. Ablation is an invasive procedure that creates scar tissue within the heart to reduce the arrhythmias, with a longer lasting effect than DCCV. It has been used with success in AF that occurs occasionally (paroxysmal) but is not as effective in AF that is more long-lasting, also known as persistent AF. Persistent AF is major cause of symptoms of breathlessness and palpitations and significantly increases the risk of stroke. Doctors are unable to accurately predict which patients will benefit most from an ablation, this can lead to as many as 50% of patients not benefitting from the procedure. The aim is to better predict which patients will benefit from an ablation. The study will include patients undergoing AF ablation or DCCV and perform additional tests including blood tests a heart MRI scan, a special type of heart tracing with up to 252 points and a short period of extra recordings from within the heart during the ablation procedure. Several techniques will be used to analyse this data, including machine learning, to develop a means predict which patients will benefit the most from the ablation procedure, without needing to use any recordings from within the heart.

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

入选标准

  • Suitable candidate for catheter mapping/ablation for arrhythmias or direct current cardioversion for atrial fibrillation
  • Signed Informed Consent

排除标准

  • Severe cerebrovascular disease
  • Moderate to severe renal impairment (eGFR < 30)
  • Active gastrointestinal bleeding
  • Active infection or fever
  • Short life expectancy
  • Significant anaemia
  • Severe uncontrolled systemic hypertension
  • Severe electrolyte imbalance
  • Congestive heart failure - NYHA Class IV
  • Recent myocardial infarction
  • Bleeding or clotting disorders
  • Uncontrolled diabetes
  • Inability to receive IV or oral Anticoagulants
  • Unable to give informed consent
  • Pregnancy

结局指标

主要结局

Freedom From Atrial Fibrillation

时间窗: 1 year

Percentage of patients who do not have a recurrence of atrial fibrillation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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