NCT03984877Unknown不适用
Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic
Javier López Pais1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
To analyze the prevalence and impact on the prognosis of amyloidosis due to transthyretin in patients with severe aortic stenosis who undergo percutaneous aortic valve implantation.
详细描述
Type and design of the study: Multicentric, prospective cohort, observational.
Number and characteristics of the patients: 321 patients to whom TAVI has been implanted due to severe degenerative AS.
Duration of the study
- Recruitment period: All consecutive patients undergoing a non-invasive diagnostic study of amyloidosis (scintigraphy with technetium pyrophosphate99 and blood protein electrophoresis) will be recruited before discharge, in centers with proven experience, will accept non-invasive diagnosis with resonance) and have an implanted percutaneous aortic prosthesis for severe aortic stenosis.
- Follow-up period: clinical and echocardiographic follow-up will be carried out before discharge, in consultation at three, six, twelve and twenty-four months.
Inclusion: 1 year
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
- 60 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic valve replacement with a percutaneous prosthesis due to severe aortic stenosis after evaluation by the Heart Team.
- •Ability to understand and sign informed consent.
- •They do not meet any of the exclusion criteria.
排除标准
- •Death as a complication of the procedure during hospitalization.
- •Associated mitral valve disease requiring intervention
- •TAVI valve-in-valve implant.
- •Does not sign informed consent.
结局指标
主要结局
Mortality
时间窗: 1 year
Survival after TAVI of patients with amyloidosis
次要结局
- Pacemaker requirements(15 days)
研究者
Javier López Pais
Sponsor-Investigator
Hospital Clinico Universitario de Santiago
研究点 (1)
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