跳至主要内容
临床试验/NCT00643188
NCT00643188已完成4 期

Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation

Biotronik SE & Co. KG32 个研究点 分布在 8 个国家目标入组 398 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
398
试验地点
32
主要终点
All-cause mortality or worsening heart failure requiring unplanned hospitalization

研究概览

简要总结

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher mortality, more frequent hospitalization, and lower quality of life. Furthermore, AF is often associated with heart failure. The majority of AF is initiated by ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation could improve cardiac function, symptoms and quality of life. It remains still unknown whether AF ablation is more effective than conventional treatment in terms of mortality and morbidity.

详细描述

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice; its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization, and decreased quality of life.

An initial approach to the cure of patients suffering from AF was surgical intervention with the Maze procedure, which involved the creation of linear lesions in the atria to break the re-entrant wavefronts responsible for maintenance of AF. Subsequently, less invasive procedures have been developed to achieve the same results. One of them is catheter based radio frequency ablation, in which a catheter is placed in the heart percutaneously, followed by application of electrical energy to the target regions, thereby creating a permanent lesion.

The origin of AF is often localized in the pulmonary veins (PVs); therefore one common approach is to ablate them in order to electrically isolate them from the left atrium (LA). Several strategies have been developed, such as linear, segmental, circumferential, and double-lasso.

Additionally, other anatomical regions such as the right atrium (RA), superior vena cava (SVC), and coronary sinus (CS) can be ablated in order to eliminate non-PV drivers of AF.

Heart failure (HF) is frequently a chronic and lethal condition, causing substantial morbidity and, after initial diagnosis, results in mortality rates which come close to or exceed those of many malignancies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs
  • Left Ventricular Ejection Fraction <= 35%
  • NYHA >= II
  • ICD for primary or secondary prevention with atrial sensing capabilities or Cardiac Resynchronization Therapy plus Defibrillator (CRT-D) device, both with Home Monitoring® technology already implanted
  • Patient is willing and able to comply with the protocol and has written informed consent
  • Age >= 18 years

排除标准

  • Contraindication for chronic anticoagulation therapy and heparin
  • Documented left atrial diameter > 6 cm
  • Previous left heart ablation procedure for atrial fibrillation
  • Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment
  • Untreated hypothyroidism or hyperthyroidism
  • Enrollment in another investigational drug or device study
  • Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age
  • Mental or physical inability to take part in the study
  • Listed for heart transplant
  • Cardiac assist device implanted
  • Planned cardiovascular intervention
  • Life expectancy ≤ 12 months
  • Uncontrolled hypertension
  • Requirement for dialysis due to terminal renal failure
  • Participation in another telemonitoring concept

结局指标

主要结局

All-cause mortality or worsening heart failure requiring unplanned hospitalization

时间窗: 7 years

次要结局

  • All-cause mortality Cardiovascular mortality Unplanned hospitalization due to cardiovascular reason Worsening heart failure requiring unplanned hospitalization Cerebrovascular accidents Left ventricular function Exercise tolerance Quality of life(7 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (32)

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