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临床试验/NCT05057507
NCT05057507已完成不适用

Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2022年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
2
主要终点
Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling

研究概览

简要总结

The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (<7 days, >7 days and >1 year). This is a cohort study. Patients undergoing clinically indicated electrophysiology study or AF ablation will have invasive assessment of cardiac electrophysiological profile at the time of their planned procedure, undergo 2-week ambulatory monitoring before and after the procedure, complete symptom questionnaires before and after their procedure and undergo atrial cardiac magnetic resonance imaging before their procedure.

详细描述

Atrial fibrillation is a common condition causing an irregular heartbeat, breathlessness and tiredness. Atrial fibrillation occurs owing to abnormalities in the electrical circuits controlling the upper heart chambers. Atrial fibrillation can be treated with a keyhole procedure called ablation. During ablation small areas in the heart are burnt away to stop the abnormal circuits causing atrial fibrillation. Unfortunately, ablation only works for 50-90% of people. We are not sure why, but possibly because the electrical circuits responsible are different in every heart. This research will examine how these electrical circuits can be identified and treated. A new system using computer modelling will be developed to identify the electrical circuits present. In the future we hope this approach could be used to design tailor-made treatments for each patient. A combination of computer studies and studies involving patients will be used to test this new approach in this study. For this study patients who are already planned to undergo an ablation procedure will be recruited providing data for three Work Packages. Consent will be sought to access routine investigations and data for research purposes (e.g. ECGs, blood tests, ambulatory monitoring, cardiac imaging, and outpatient clinical assessment); and collect extra data for research including additional cardiac imaging, a 2-week heart monitor pre- and post-ablation, and extra electrical measurements made during the ablation procedure.

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

入选标准

  • Symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation diagnosed - within 24 months preceding the consent date.
  • Planned radiofrequency ablation for atrial fibrillation consisting of pulmonary vein isolation.
  • Able and willing to comply with study follow-up requirements
  • Able and willing to provide written informed consent

排除标准

  • Any clinical contra-indication to ablation
  • Any disease limiting life expectancy to < 1year
  • Contra-indication to MRI including renal dysfunction (eGFR<30ml/min)
  • Potential participant currently pregnant or breast feeding
  • Prior ablation, cardiac surgery or presence of any prosthetic valves
  • Myocardial infarction or percutaneous coronary intervention within 3 months preceding consent date
  • Hypertrophic cardiomyopathy or other inherited cardiac condition
  • Presence / likely implant of any pacemaker, cardiac resynchronization therapy device or implantable defibrillator within 1 year
  • Enrolment in an existing interventional atrial fibrillation study which alters treatment or follow-up.
  • Use of amiodarone for any indication within 6 months prior to the planned ablation procedure
  • Use of any anti-arrhythmic drug for an arrhythmia indication other than atrial fibrillation
  • Prior documented cavotricuspid isthmus dependent right atrial flutter and planned cavotricuspid isthmus ablation to be performed at the time of atrial fibrillation ablation
  • Unable to understand verbal or written explanations given in English or German as appropriate.

研究组 & 干预措施

Atrial fibrillation patients undergoing radiofrequency catheter ablation

Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.

干预措施: Atrial electro-anatomic mapping (Diagnostic Test)

Atrial fibrillation patients undergoing radiofrequency catheter ablation

Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.

干预措施: Atrial cardiac magnetic resonance imaging (Diagnostic Test)

Atrial fibrillation patients undergoing radiofrequency catheter ablation

Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.

干预措施: Atrial fibrillation symptom questionnaire (Other)

Atrial fibrillation patients undergoing radiofrequency catheter ablation

Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.

干预措施: Patch-based 2 week ambulatory monitor (Diagnostic Test)

结局指标

主要结局

Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling

时间窗: 4 years

The primary outcome is the creation of patient specific computational models for the investigation of atrial fibrillation mechanisms in patients. Mechanisms of atrial fibrillation will be defined based on computational modelling results and each patient will be assigned to the dominant mechanism of atrial fibrillation present.

次要结局

  • Treatment effects - burden of atrial fibrillation in patients classified as 'successfully treated' compared to those classified as 'not successfully treated' using the modelling framework (as defined in Outcome 1)(4 years)
  • Atrial properties - atrial structural and functional properties will be compared between patients in each mechanistic atrial fibrillation group (as defined in Outcome 1)(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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