Totally Endoscopic Ablation of Atrial Fibrillation (TEA)
Primary Objective To evaluate the efficiency of totally endoscopic ablation of AF compared to rate control management of AF.
Secondary Objectives
Does totally endoscopic ablation:
- reduce atrial fibrillation symptoms?
- increase working capacity and improve quality of life?
- improve atrial function?
- reduce the risk for stroke?
研究概览
详细说明
This is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent AF of more than one year duration and in the absence of other severe cardiopulmonary disease. One of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. The patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written Informed Consent. Study duration per patient is 12 months.
After inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. The patient will be asked to complete two health related questionnaires SF 36 and SCL and a transthoracic echocardiography will be conducted together with an exercise test.
The patients will thereafter be assessed according to randomisation. Irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and Reveal implantation or just Reveal implantation (control group). All patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Örebro、瑞典、70285
- Örebro University Hospital
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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:
- Age > 50 years
- Longstanding persistent AF of > 1 year duration
- Severe symptoms related to AF
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Exclusion Criteria:
- Severe ischemic heart disease or heart valve disease
- Thrombus formation in left atrial appendage
- Intolerance to warfarin medication
- Advanced pulmonary disease, FEV 1 < 1.5 litre
- Left atrial diameter > 60 mm
- Body Mass Index (BMI) > 35 kg/m2
- Previous pulmonary or heart surgery
- Participation in another clinical trial within the last 30 days prior to enrollment
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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有源比较器：速率控制
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Anti-arrhythmic protocol The control group is using a rate-control strategy.
All patients keep their anti-arrhythmic/beta-blocker/digoxin medication during the entire follow-up.
No attempts are made to rhythm-control the patients, unless subjective symptoms make it necessary.
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实验性的：Endoscopic ablation of atrial fibrillation
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The procedure is conducted in general anaesthesia. The right chest is entered with three working ports . After a complete cycle of ablation creating a box lesion in the left atrium, conduction block is tested. A chest tube is placed through the most caudal port and the port incisions are closed. A Reveal loop recorder is then implanted subcutaneously. The patient is extubated and transferred to postoperative care. |
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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Freedom of AF 3 - 12 months postoperatively without antiarrhythmic drugs
大体时间：3-12 months
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3-12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Freedom of symptomatic AF episodes 3 - 12 months
大体时间：3-12 months
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3-12 months
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Exercise capacity after 12 months
大体时间：12 months
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12 months
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Quality-of-life assessment (SF-36 and SCL) 3, 6 and 12 months
大体时间：12 months
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12 months
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Atrial function and dimensions after 6 and 12 months
大体时间：12 months
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12 months
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Freedom of thromboembolic events during the study
大体时间：12 months
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12 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Anders Ahlsson, MD PhD、Department of Cardiothoracic Surgery
- 学习椅：Espen Fengsrud, MD、Department of Cardiology
- 研究主任：Anders Englund, MD PhD、Stockholm Arrhythmia Center
- 学习椅：Peter Linde, MD、Department of Cardiology
- 学习椅：Henrik Almroth, MD、Department of Cardiology
- 学习椅：Tommy Andersson, MD、Department of Cardiology
- 学习椅：Hans Tyden, MD PhD、Department of Cardiothoracic Surgery
出版物和有用的链接
一般刊物
- Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S; Task Force on Practice Guidelines, American College of Cardiology/American Heart Association; Committee for Practice Guidelines, European Society of Cardiology; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J. 2006 Aug;27(16):1979-2030. doi: 10.1093/eurheartj/ehl176. No abstract available. Erratum In: Eur Heart J. 2007 Aug;28(16):2046.
- European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Scoiety (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS); Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ. HRS/EHRA/ECAS expert Consensus Statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007 Jun;4(6):816-61. doi: 10.1016/j.hrthm.2007.04.005. Epub 2007 Apr 30. No abstract available. Erratum In: Heart Rhythm. 2009 Jan;6(1):148.
- Matsutani N, Takase B, Ozeki Y, Maehara T, Lee R. Minimally invasive cardiothoracic surgery for atrial fibrillation: a combined Japan-US experience. Circ J. 2008 Mar;72(3):434-6. doi: 10.1253/circj.72.434.
- Sagbas E, Akpinar B, Sanisoglu I, Caynak B, Tamtekin B, Oral K, Onan B. Video-assisted bilateral epicardial pulmonary vein isolation for the treatment of lone atrial fibrillation. Ann Thorac Surg. 2007 May;83(5):1724-30. doi: 10.1016/j.athoracsur.2006.12.009.
- Wolf RK, Schneeberger EW, Osterday R, Miller D, Merrill W, Flege JB Jr, Gillinov AM. Video-assisted bilateral pulmonary vein isolation and left atrial appendage exclusion for atrial fibrillation. J Thorac Cardiovasc Surg. 2005 Sep;130(3):797-802. doi: 10.1016/j.jtcvs.2005.03.041. Erratum In: J Thorac Cardiovasc Surg. 2006 Apr;131(4):772.
- La Meir M, De Roy L, Blommaert D, Buche M. Treatment of lone atrial fibrillation with a right thoracoscopic approach. Ann Thorac Surg. 2007 Jun;83(6):2244-5. doi: 10.1016/j.athoracsur.2006.08.004.
- Fengsrud E, Wickbom A, Almroth H, Englund A, Ahlsson A. Total endoscopic ablation of patients with long-standing persistent atrial fibrillation: a randomized controlled study. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):292-8. doi: 10.1093/icvts/ivw088. Epub 2016 Apr 10.
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
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