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临床试验/NCT02241447
NCT02241447已完成不适用

Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry

Institut für Pharmakologie und Präventive Medizin23 个研究点 分布在 9 个国家目标入组 2,173 人开始时间: 2014年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,173
试验地点
23
主要终点
Referral rates at 3 months for Intervention (SAVR or TAVI)

研究概览

简要总结

The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.

详细描述

All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on. There will also be an optional telephone follow-up to find out the patient's outcome.

Intervention: In this phase, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.

Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented.

Observation B: Same as Observation Phase A

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
否

入选标准

  • •Aortic valve area < 1cm2
  • •Indexed aortic valve area <0.6 cm/m2
  • •Maximum Jet velocity > 4.0 m/sec
  • •Mean transvalvular gradient > 40 mmHg

排除标准

  • •Non-severe aortic Stenosis (AS)
  • •Previous aortic valve replacement (AVR)

结局指标

主要结局

Referral rates at 3 months for Intervention (SAVR or TAVI)

时间窗: 3 months

次要结局

  • Time to next out-patient appointment or clinical review(15 months)
  • Appropriateness of treatment decisions made in collaboration with the valve specialist(3 months)
  • Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)(3 months)
  • Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment(3 months)
  • Referral rates at 3 months for exercise testing or stress echocardiography(3 months)

研究者

发起方
Institut für Pharmakologie und Präventive Medizin
申办方类型
Network
责任方
Sponsor

研究点 (23)

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