ISRCTN17309312已完成未知
Isoprenaline infusion as a method of induction of Atrial Fibrillation: a randomised controlled trial investigating the use of Isoprenaline to induce an episode of atrial fibrillation
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust0 个研究点目标入组 235 人开始时间: 2015年1月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 235
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All participants in all groups:
- •1. The participant must be willing to comply with the protocol requirements including travelling to the investigating hospital for the attendances required for the study
- •2. Provision of informed consent
- •3. Participants must be over 18 years of age
- •Group 1 – Paroxysmal Atrial Fibrillation Group
- •1. Participants must have a history of arrhythmia with 12 lead ECG or ambulatory ECG monitoring recordings documenting a diagnosis of atrial fibrillation
- •2. Participants must have a pattern of symptoms and investigation results consistent with a diagnosis of paroxysmal atrial fibrillation
- •Group 2 – SVT Ablation Group
- •1. Participants must have a history of arrhythmia with documented regular, narrow complex tachycardia available on either 12 lead ECG or ambulatory ECG monitor recording
- •2. Participants must be listed to undergo an Electrophysiology study with a view to performing an ablation procedure
- •3. Participants must go on to have an ablation procedure for either AtrioVentricular Reentrant Tachycardia (AVRT) or AtrioVentricular Nodal Reentrant Tachycardia (AVNRT) with a defined procedural endpoint
- •Group 3 – Atrial Flutter Ablation Group
- •1. Participants must have a history of arrhythmia with 12 lead ECG documentation fulfilling prespecified criteria for diagnosis of common type (cavotricuspid isthmus dependent) atrial flutter
- •2. Participants must be listed to undergo a cavotricuspid isthmus ablation for common type atrial flutter
- •3. Participants must go on to have only a cavotricuspid isthmus ablation for common type atrial flutter
- •4. Sustained bidirectional cavotricuspid isthmus block must have been demonstrated as the endpoint for the ablation procedure
- •Group 4 – Pulmonary Vein Isolation Group
- •1. Participants must have a history of arrhythmia with 12 lead ECG or ambulatory ECG monitoring recordings documenting a diagnosis of atrial fibrillation
- •2. Participants must be listed to undergo an ablation procedure for atrial fibrillation with the intent of the attending physician to perform pulmonary vein isolation alone as an ablation strategy
- •3. Participants must be in sinus rhythm at the time that they enter the Cardiac Electrophysiology Laboratory for their
- •ablation procedure.
- •4. Participants must have an ablation procedure for atrial fibrillation and this must have involved only ablation to achieve pulmonary vein isolation
- •5. Pulmonary vein isolation must have been demonstrated as the endpoint for the ablation procedure
排除标准
- •All participants in all groups:
- •1. Allergy to Isoprenaline
- •2. Any treatment with Amiodarone in the 3 months prior to ablation procedure
- •3. Hypertrophic cardiomyopathy
- •4. Suspected acute myocarditis
- •5. Uncorrected, severe valvulopathy graded by transthoracic echocardiographic parameters
- •6. An Acute Coronary Syndrome within the last 6 months
- •7. Recent (within the last 6 months) or scheduled coronary revascularisation
- •8. Ongoing angina symptoms without investigations demonstrating the absence of myocardial ischaemia
- •9. Left ventricular ejection fraction measured at <30%
- •10. Symptoms of decompensated heart failure syndrome in the last 3 months
- •11. Severe obstructive lung disease
- •12. Pregnancy at the time of enrolment or a desire to become pregnant during the study period
- •13. Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
- •14. Unable to provide informed consent
- •Group 1 – Paroxysmal Atrial Fibrillation Group
- •15. Any past history of episode of persistent atrial fibrillation at the time of enrolment to the study
- •16. Treatment with any antiarrhythmic agent within six halflives
- •of that agent from before an administration of the study
- •drug infusion
- •Group 2 – SVT Ablation Group
- •1. Any past history of atrial fibrillation documented on 12 lead ECG or ambulatory ECG monitor
- •2. Any past history of atrial flutter documented on 12 lead ECG or ambulatory ECG monitor
- •3. Characterisation of SVT as any arrhythmia other than ANRT or AVNRT
- •4. Treatment with any antiarrhythmic agent within six halflives
- •of that agent from the ablation procedure (including intraprocedural
- •use) with the exception of isoprenaline and adenosine
- •Group 3 – Atrial Flutter Ablation Group
- •1. Characterisation of arrhythmia as any arrhythmia other than cavotricuspid
- •isthmus dependent atrial flutter at the time
- •of ablation
- •2. Treatment with any antiarrhythmic agent within six halflives
- •of that agent from the ablation procedure (including intraprocedural
- •use) with the exception of isoprenaline and adenosine
- •Group 4 – Pulmonary Vein Isolation Group
- •1. Requirement for a more extensive ablation strategy than pulmonary vein isolation alone
- •2. Intraprocedural treatment with any antiarrhythmic agent with the exception of isoprenaline and adenosine
- •3. Treatment with any antiarrhythmic agent in the days before the ablation within six halflives of that agent from the ablation procedure
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