Medical Economical Evaluation of the Ablation by Catheter of the Atrial Tissue in the Treatment of the Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Success of ablation
研究概览
简要总结
The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia increases with the age, and the investigators consider that beyond 65 years, 5 % of the population is affected by this arrhythmia. It entails a greater risk of morbidity (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the associated risk factors. For all these reasons, it raises a real problem of public health.
详细描述
The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia increases with the age, and we consider that beyond 65 years, 5 % of the population is affected by this arrhythmia. It entails a greater risk of morbidity (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the associated risk factors. For all these reasons, it raises a real problem of public health.
The medical treatment of PAROXYSTIC or persistent atrial fibrillation associates antiarrythmic and anticoagulant. The purpose of it is to maintain the sinusal rhythm and to prevent the thromboembolic complications. The success rate of the treatment antiarrythmic is disappointing, not exceeding, on average, 50 % with 1 year. In addition the incidence of the side effects of these molecules as that of the anticoagulants is far from being negligible.
Other not-pharmacological therapeutic alternatives were proposed among resistant patients, such final cardiac stimulation whose results are not currently very convincing. Ablation by catheter is, except the surgery whose indications are exceptional, the only curative treatment of AF. The complications of the procedure are rare (1 to 2%), but they can be severe. The indication of ablation for which there is currently a consensus is that of AF PAROXYSTIC repeating or persistent, symptomatic, on c?ur normal or pathological, resistant to at least 1 major treatment antiarrythmic. The effectiveness of ablation was validated by many studies within the framework of PAROXYSTIC or persistent AF in very specialized centers. The diffusion of this mode of treatment is limited in our country where very few centers practise it because of a long and difficult training of the technique, claiming a great expertise, but also of the need for human and material means important. The number of ablations carried out in the consensual indications in 2003 in France was approximately 450. This figure is very weak compared to the prevalence of this disorder of the rate/rhythm. This leads in the few centers invested to long withdrawal periods for the patient whom can reach 4 to 12 months.
Awaited benefit of ablation by catheter:
- reduction of the costs of health thanks to the suppression of any treatment and with a reduction of the duration and frequency of the hospitalizations and consultations
- faster rehabilitation of the patients in the active life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonspontaneous and ≤90 days) symptomatic and dating of more than 6 months
- •Patient in failure of at least 1 antiarrythmic major (Class Ic or amiodarone) or repeats after at least 1 medicamentous or electric reduction
- •Patient having presented at least 1 episode of F documented by ECG or Holter
- •Patient having a medical history of AF which can be reconstituted retrospectively over the last 12 months
- •Patient currently under anticoagulant treatment by AVK balanced
排除标准
- •Patient presenting asymptomatic AF
- •Patient presenting AF permanent (90 days)
- •Patient presenting a counter-indication at the anticoagulants by oral way
- •Patient presenting of the antecedents of ablation of AF
- •Patient presenting an intracardiac thrombus
- •Patient presenting reversible AF of cause
结局指标
主要结局
Success of ablation
时间窗: after 3 months
The principal criterion of the medical evaluation is the success of ablation defined by the absence of repetition of AF (or the persistence of the sinusal rhythm) after the 3 months period following the procedures of ablation based on ECG or holter registration. These patients are likely to be able to profit from another procedure of ablation so necessary.
次要结局
未报告次要终点