EUCTR2011-002532-12-DE进行中（未招募）1 期
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial - CABANA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 2,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Over the preceding 6 months have:
- •a) >= 2 paroxysmal (electrocardiographic documentation of at least 1) AR episodes lasting >Z= 1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset); or
- •b) electrocardiographic documentation of 1 persistent AF episode (sustained for 7>= days or cardioversion is performed more than 48H after AF onset); or
- •c) electrocardiographic documentation of 1 longstanding persistent AF episode (continuos AF of duration > 1.
- •2.Warrant active therapy (within the past 3 months) beyond simple ongoing observation
- •3.Be eligible for catheter ablation and =2 sequential rhythm control and/or =2 rate control drugs.
- •4.Be =65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose =126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index =40 cc/m2), or EF =35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.
- •5.Have the capacity to understand and sign an informed consent form.
- •6.Be =18 years of age.
- •NOTE: providing they remain realistically eligible for =2 membrane active drugs and/or =2 rate control agents. Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •1. Lone AF in the absence of risk factors for stroke in patients <65 years of age
- •2. Patients who in the opinion of the managing clinician should not yet receive any therapy
- •3. Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic
- •dose due to inefficacy or side effects (Table 5.2.2)
- •4. An efficacy failure of full dose amiodarone treatment >= 8weeks duration at any time
- •5. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent
- •major surgical procedures, or trauma
- •6. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3
- •7. Hypertrophic obstructive cardiomyopathy (outflow track)
- •8. Class IV angina or Class IV CHF (including past or planned heart transplantation)
- •9. Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)
- •10. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
- •11. Prior LA catheter ablation with the intention of treating AF
- •12. Prior surgical interventions for AF such as the MAZE procedure
- •13. Prior AV nodal ablation
- •14. Patients with other arrhythmias requiring ablative therapy
- •15. Contraindication to appropriate anti-coagulation therapy
- •16. Renal failure requiring dialysis
- •17. Medical conditions limiting expected survival to <1 year
- •18. Women of childbearing potential (unless post-menopausal or surgically sterile)
- •19. Participation in any other clinical mortality trial
- •20. Unable to give informed consent.
- •Note: Planned atrial flutter ablation in combination with the left atrial
- •ablation is not an exclusion. Exclusion Criterion #3 includes failed membrane active antiarrhythmic drugs started within 3 months prior to enrollment.
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