NCT03088787Unknown不适用
Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the distinctive morphological characteristics of the aortic pressure waveform
研究概览
简要总结
The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •o Patients with severe senile degenerative aortic valve stenosis
- •Clinical team agrees on eligibility including assessment that TAVR is appropriate for the subject
- •Patients undergoing TAVR via the femoral approach
- •Patients who normally require a guiding catheter for central aortic pressure monitoring during the TAVR procedure
- •Patient must be 18 years old or older
- •Patient, or legally authorized representative, has given consent to be in the study
- •Patient height and weight are available prior to study
- •Ability to perform a Nexfin measurement at the left hand side.
排除标准
- •o Patients with contraindications for placement of aortic catheter
- •Patients with mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified
- •Patients being treated with an intra-aortic balloon pump
- •Patients less than 40 kg in weight
- •Female patients of childbearing potential with a known pregnancy
- •Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
结局指标
主要结局
the distinctive morphological characteristics of the aortic pressure waveform
时间窗: During procedure and 4 hours after
the distinctive morphological characteristics of the aortic pressure waveform
次要结局
- changes in hemodynamic variables after TAVR and its influence on cardiac recovery.(during procedure and up to 6 weeks after intervention)
研究者
D.P.Veelo
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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