Future Optimal Research and Care Evaluation - Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Quality of life as assessed by the EQ-5D-5L
研究概览
简要总结
In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.
Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years of age
- •Severe or moderate aortic stenosis
- •No exclusion criteria are applicable to this registry
排除标准
- 未提供
结局指标
主要结局
Quality of life as assessed by the EQ-5D-5L
时间窗: Until completion of the study (August 1, 2027)
The EQ-5D-5L is a standardized health-related quality of life instrument that assesses individuals across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It generates a health profile that can be converted into a single index value, commonly ranging from -0.594 to 1, where 1 represents full health, 0 indicates a state equivalent to death, and negative values reflect health states perceived as worse than death.
Quality of life as assessed by the SF-12
时间窗: Until completion of the study (August 1, 2027)
The Short Form 12 (SF-12) is a widely used health survey that measures health-related quality of life across physical and mental domains. It generates two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both ranging from 0 to 100, where higher scores indicate better health status, and these summaries provide a concise assessment of an individual's overall physical and mental well-being.
Quality of life as assessed by the KCCQ
时间窗: Until completion of the study (August 1, 2027)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific instrument assessing heart failure patients across domains such as Total Symptoms, Physical Limitation, and Quality of Life, with scores ranging from 0 to 100. Higher scores indicate better health-related quality of life, while lower scores suggest increased symptomatology and functional limitations in heart failure patients.
次要结局
- Other procedural or valve-related complications according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Bioprosthetic valve dysfunction according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Mortality according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Bleeding and transfusions according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Vascular and access-related complications according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- New conduction disturbances and arrhythmias according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Neurological events according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Hospitalisation according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Cardiac structural complications according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Acute kidney injury according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Myocardial infarction according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Clinically significant valve thrombosis according the VARC-3 criteria(Until completion of the study (August 1, 2027))
- Leaflet thickening and reduced motion according the VARC-3 criteria(Until completion of the study (August 1, 2027))
研究者
Jurriën M. ten Berg, MD, PhD
Clinical Professor
St. Antonius Hospital