EUCTR2011-002532-12-CZ进行中（未招募）不适用
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial - CABANA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 3,000
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
- •1. Have documented AF episodes =1 hour in duration; with =2 episodes
- •over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week
- •2. Warrant active therapy beyond simple ongoing observation.
- •3. Be eligible for catheter ablation and= 2 sequential rhytmn control and/or =3 rate control.
- •4. Be =65 years of age, or <65 years with one or more of the following risk factors of stroke: Hypertension defined as BP >140/90 mmHg Diabetes defined as a fasting glucose=126 mg/dl, Congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0 cm (or volume index = 40cc/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 quality.
- •5. Have the capacity to understand and sign an Informed concent form.
- •6. Be =18 years of age.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
- •1. Have documented AF episodes =1 hour in duration; with =2 episodes
- •over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week
- •2. Warrant active therapy beyond simple ongoing observation.
- •3. Be eligible for catheter ablation and= 2 sequential rhytmn control and/or =3 rate control.
- •4. Be =65 years of age, or <65 years with one or more of the following risk factors of stroke: Hypertension defined as BP >140/90 mmHg Diabetes defined as a fasting glucose=126 mg/dl, Congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0 cm (or volume index = 40cc/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 quality.
- •5. Have the capacity to understand and sign an Informed concent form.
- •6. Be =18 years of age.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 for AF
- •3. Patients who have failed =2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
- •4. More than one week of amiodarone treatment in the past 3 months
- •5. An efficacy failure of full dose amiodarone treatment =12 weeks duration at any time
- •6. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
- •7. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
- •8. Hypertrophic obstructive cardiomyopathy
- •9. Class IV angina or Class IV CHF (including past or planned heart transplantation) 10. Other mandated anti-arrhythmic drug therapy
- •11. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
- •12. Prior LA catheter ablation with the intention of treating AF
- •13. Prior surgical interventions for AF such as the MAZE procedure
- •14. Prior AV nodal ablation
- •15. Patients with other arrhythmias requiring ablative therapy
- •16. contraindication to warfarin anti-coagulation
- •17. Renal failure requiring dialys
- •18. Medical conditions limiting expected survival to <1 year
- •19. Women of childbearing potential (unless post-menopausal or surgically sterile)
- •20. Participation in any other clinical mortality trial
- •21. Unable to give informed consent
- •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 for AF
- •3. Patients who have failed =2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
- •4. More than one week of amiodarone treatment in the past 3 months
- •5. An efficacy failure of full dose amiodarone treatment =12 weeks duration at any time
- •6. Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
- •7. Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
- •8. Hypertrophic obstructive cardiomyopathy
- •9. Class IV angina or Class IV CHF (including past or planned heart transplantation) 10. Other mandated anti-arrhythmic drug therapy
- •11. Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
- •12. Prior LA catheter ablation with the intention of treating AF
- •13. Prior surgical interventions for AF such as the MAZE procedure
- •14. Prior AV nodal ablation
- •15. Patients with other arrhythmias requiring ablative therapy
- •16. contraindication to warfarin anti-coagulation
- •17. Renal failure requiring dialys
- •18. Medical conditions limiting expected survival to <1 year
- •19. Women of childbearing potential (unless post-menopausal or surgically sterile)
- •20. Participation in any other clinical mortality trial
- •21. Unable to give informed consent
研究者
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