Observatoire Des Assistances Monoventriculaires Gauches du Grand Sud
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
Chronic heart failure is a common disease. It is also a serious disease with a mortality of 50% at 5 years, representing a significant cost in terms of public health expenditure.
Heart transplantation represents the "gold standard" of care for terminal heart failure patients reached the end of the disease despite optimal medical and surgical management of their disease, with a survival rate of transplant patients by 90% at 1 year and 82% at 3 years.
Long term LVAD are an innovative technology available for more than a decade, developed in part because of the shortage of cardiac grafts and high mortality among patients waiting for transplants due to an important pending.
This technique is used substantially only for ten to fifteen years in the world. Survival after implantation of latest devices reaches 80% at 1 year.
In France, this technique is intended for patients with terminal heart failure who ended different pharmacological and invasive therapeutic resources available.
Currently, academic centers that offer the possibility of long-term LVAD support are organized unicentric in order to centralize specialized care for these patients.
Indeed, patients candidates for the establishment of a long-term LVAD are rigorously selected to ensure an acceptable survival.
However, practices vary considerably from one center to another in particular regarding:
- Implantation indications,
- Pre-implantation patient assessment,
- Monitoring,
- Implementation of pharmacological treatments, particularly anticoagulants or betablockers.
详细描述
Methods:
It's a prospective multicentric observational study realised on 3 University Hospital in France: Bordeaux, Montpellier and Toulouse.
Population:
All patients undergoing implantation of a long-term LVAD support whatever the brand and type, on one of the 3 participating centers (Montpellier, Toulouse or Bordeaux) during the 3 years period, after approval of informed consent.
Patients were followed up at 1 and 6 months, and 1 year as part of their routine management of their disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing implantation of LVAD support whatever make and type on one of the 3 participating centers (University Hospital of Montpellier, Toulouse and Bordeaux) during the period
- •Free, informed and signed consent
- •Men or women Patients should have agreed to participate in the observatory, knowing that participation or refusal to participate will not alter the therapeutic attitude of the physician responsible for the patient. Study of phenotypic characteristics will not change the therapeutic approach of the medical teams.
排除标准
- •Patient unable to understand the nature and goals of the study and / or communication difficulties with the investigator
- •Major protected by law (guardianship, curatorship or under judicial protection)
- •Patient deprived of liberty by judicial or administrative decision
结局指标
主要结局
Mortality rate
时间窗: 1 year
Mortality rate after one year for patients included in the research
次要结局
- Mortality rate(6 months)
- vital function(3 months)
- Cardiovascular death rates(1 year)