DIVER-TAVI Registry - Demographic and Interpopulation Variations in Evaluation and Results of TAVI
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 800
- 试验地点
- 5
- 主要终点
- Aortic annulus diameter
研究概览
简要总结
The aim of the project is to evaluate demographic, clinical, and laboratory variations in patients with aortic stenosis treated with TAVI in different countries. Moreover, the study will evaluate interpopulation differences in aortic root anatomy based on computed tomography analysis.
详细描述
Aortic stenosis represents the most common valvular heart disease in developed countries, with a significant epidemiologic increase related to the aging population. Currently, surgical and transcatheter interventions are the only therapeutic options, as pharmacotherapy is still insufficient in the disease management. Transcatheter aortic valve implantation is recommended in selected groups of patients and provides optimal short and long-term outcomes.
Racial and ethnic disparities in aortic stenosis prevalence, management, and outcomes of treatment have been postulated. Data on discrepancies in aortic stenosis characteristics in patients qualified for transcatheter aortic valve implantation across populations are lacking.
The current project will conduct the analysis in populations of patients with aortic stenosis qualified for transcatheter aortic valve implantation from different countries to reveal potential disparities in clinical characteristics and in requirements for variations in prostheses sizes.
This is a retrospective, multicentre, observational registry of patients with severe aortic stenosis qualified for transcatheter aortic valve implantation.
Inclusion criteria - each site will include consecutive 100 patients who underwent transcatheter aortic valve implantation between January and June 2025.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Severe aortic stenosis qualified for TAVI
排除标准
- •Active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)
结局指标
主要结局
Aortic annulus diameter
时间窗: Baseline
Aortic annulus diameter in milimeters based on CT image
Aortic annulus area
时间窗: Baseline
Aortic annulus area in squared milimeters based on CT image
Aortic annulus perimeter
时间窗: Baseline
Aortic annulus perimeter in milimeters based on CT image
Ilio-femoral artery diameter
时间窗: Baseline
Ilio-femoral artery diameter in milimeter based on CT image
Neutrophils measured using whole blood count
时间窗: Baseline
This measurement is used to compute ratio of cell types using whole blood count
Monocytes measured in whole blood count
时间窗: Baseline
Number of monocytes identified in blood sample using automatic whole blood count. It is used to compute cell type ratio.
Lymphocytes measured using whole blood count
时间窗: Baseline
This measurement is used to compute ratio of cell types using whole blood count
次要结局
未报告次要终点