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临床试验/NCT02713932
NCT02713932Unknown不适用

The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Major adverse events

研究概览

简要总结

The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve is a prospective Italian registry including several centers performing TAVI, collecting baseline, procedural and outcome data.

详细描述

Aortic valve stenosis is the most common degenerative valve disease in the elderly, the prevalence is about 1-2% in the age group> 65 years and 4% in patients aged> 85. The natural history is characterized by a poor prognosis with a survival rate of 62% at 1 year, 32% at 5 years and 18% at 10 years from symptom onset. Predictors of death were age> of 75 years, poor left ventricular ejection fraction, congestive heart failure, chronic obstructive pulmonary disease, severe mitral regurgitation and pulmonary hypertension.

The gold standard therapy, with improved survival, for severe aortic stenosis is the surgical aortic valve replacement with mechanical or biological prosthesis. Cardiac surgery is therapy of choice for patients with severe aortic valve stenosis with left ventricular dysfunction or when symptomatic for lipothymia or syncope, angina pectoris, heart failure.

Criteria for high surgical risk are: left ventricular failure, coronary artery disease, previous cardiac surgery for coronary artery bypass , chronic obstructive pulmonary disease, and/or advanced age and comorbidity , which can be a contraindication to intervention. Frequently cardiac surgery is not performed in elderly patients for the high surgery risk. In the Euro Heart Survey up to 33% of patients with single valve disease, New York Heart Association class III or IV, were not operated for concomitant disease or reduced life expectancy.

The need to provide a therapeutic option for patients considered at high surgery risk, has stimulated the development of prosthetic valve implantable with a percutaneous transcatheter techniques. The percutaneous treatment of valvular aortic stenosis has potential advantages in terms of reduction of hospitalization of elderly patients with high risk of peri-operative mortality and morbidity, as well as avoiding treatment with oral anticoagulants. The experience up to now is very positive, with immediate favorable results in terms of hemodynamic and clinical improvement. Since the procedure is at initial stage of clinical application, it becomes necessary a uniform and standardized data collection to assess the effectiveness of the procedure, the incidence of acute and late complications, and the performance of the biological valve prosthesis.

The investigators propose the establishment of an observational registry of percutaneous aortic valve replacement performed in the Italian Interventional Cardiology Laboratory.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in whom transcatheter aortic valve implantation is attempted at participating center.

排除标准

  • None except failure to obtain informed consent.

结局指标

主要结局

Major adverse events

时间窗: Up to 24 months

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Testa

Consultant Cardiologist

IRCCS Policlinico S. Donato

研究点 (1)

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