Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation (Hansen)
Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial
Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. It is a complex procedure to perform so only a few hospitals are able to offer this treatment in the UK. A new technology allows the operator to guide their catheters (thin wires) in the patient by using a robotically steered sheath. This allows accurate and precise navigation that may improve the accuracy and integrity of ablation. We aim to prove whether this technology can make AF ablation easier and more effective.
Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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London、英国、EC1A 7BE
- Barts and the London NHS Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients with symptomatic AF planned for catheter ablation.
Exclusion Criteria:
- Age < 18 years
- Previous ablation procedure
- Expected life expectancy < 6 months
- Inability or unwillingness to sign consent
- Pregnancy
- Contraindications for the ablation procedure o Thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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其他：manual ablation
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ablation procedure performed with Hansen robotic navigation system
Ablation will be performed as normal treatment
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实验性的：robotic ablation
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ablation procedure performed with Hansen robotic navigation system
Ablation will be performed as normal treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Single procedure success rate at 12 months
大体时间：12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
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Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue
大体时间：0-12 months
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0-12 months
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Platelet substudy: Platelet activation post ablation compared to baseline.
大体时间：3 months
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3 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Ullah W, McLean A, Hunter RJ, Baker V, Richmond L, Cantor EJ, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Randomized trial comparing robotic to manual ablation for atrial fibrillation. Heart Rhythm. 2014 Nov;11(11):1862-9. doi: 10.1016/j.hrthm.2014.06.026. Epub 2014 Jun 21.
- Duncan ER, Finlay M, Page SP, Hunter R, Goromonzi F, Richmond L, Baker V, Ginks M, Ezzat V, Dhinoja M, Earley MJ, Sporton S, Schilling RJ. Improved electrogram attenuation during ablation of paroxysmal atrial fibrillation with the Hansen robotic system. Pacing Clin Electrophysiol. 2012 Jun;35(6):730-8. doi: 10.1111/j.1540-8159.2012.03381.x. Epub 2012 Apr 11.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
catheter ablation的临床试验
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Charles University, Czech RepublicUniversity Hospital Olomouc; General University Hospital, Prague; Cardiocenter Podlesí, Trinec...终止
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CSA Medical, Inc.终止