ISRCTN78204941已完成未知
BACE-PACE-Trial - A multicenter study to investigate preventive pacing in combination with antiarrhythmic beta-blocker or AT-I-/angiotensin converting enzyme (ACE)-inhibitor therapy on the recurrence of atrial fibrillation (AF) in patients with dual-chamber pacemakers
German Atrial Fibrillation Network0 个研究点目标入组 224 人开始时间: 2005年10月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 224
研究概览
简要总结
2008 Protocol article in https://doi.org/10.1007/s12181-008-0128-3 (added 28/10/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Idiopathic paroxysmal symptomatic atrial fibrillation
- •2. Implantation of a fully functional pacemaker (e.g. normal impedance, stimulation thresholds and sensing values) Vitatron Selection 9000, Prevent AF, T 70 DR 2-4 months ago, because of one of the following indications: symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome
- •3. Symptomatic sinuatrial block
- •4. High-grade AV-Block (AV Block II und III)
- •5. Binodal disease: Sick-Sinus-Syndrome and high-grade AV-Block
- •6. AV-Nodal-Ablation in combination with a pacemaker therapy ('Ablate & Pace')
- •7. Written informed consent of the patient
- •8. Age >18 years
排除标准
- •1. Chronic heart failure (New York Heart Association [NYHA] III/IV)
- •2. Acute myocardial infarction <6 months
- •3. Hypertrophic obstructive cardiomyopathy
- •4. Symptomatic hypo- or hyperthyreosis
- •5. Instable angina pectoris
- •6. Cardiogenic shock
- •7. Patients with diabetes mellitus and recurrence of hypoglycaemia
- •8. Pregnancy or breast feeding
- •9. Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
- •10. Reduced life expectancy (<6 months)
- •11. Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
- •12. Evidence of an uncooperative attitude
研究者
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