The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Subclinical Leaflet Thrombosis
研究概览
简要总结
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.
详细描述
Subclinical leaflet thrombosis (SCLT) occurs frequently after TAVI and has been associated with an increased risk of valve dysfunction. A persistent form of SCLT may lead to thrombus calcification and valve degeneration and increase the long-term risk of symptomatic bioprosthetic valve deterioration. Intra-annular in comparison to supra-annular TAVI valves have been associated with a higher risk of SCLT and valve thrombosis. Intra-annular valves may create larger neo-sinuses and flow stagnation zones, which favour local thrombogenicity. Whether different prosthesis types lead to a higher degree of transcatheter valve calcification and degeneration is currently unexplored. Recently, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET) has emerged as a non-invasive modality capable of imaging bioprosthetic micro-calcification activity, which is an early and powerful predictor of valvular dysfunction and eventually valve failure. In the present study, we investigate for the first time, the differences in quantified bioprosthetic micro-calcification activity with 18F-NaF PET as early marker of transcatheter valve degeneration between patients with and without SCLT and between patients with intra-annular vs. supra-annular prostheses at five years after TAVI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago
- •Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography
- •Written informed consent
排除标准
- •Temporary or chronic oral anticoagulation use after TAVI
- •Known severe renal insufficiency
- •Known severe paravalvular regurgitation
- •History of valve-in-valve procedure
- •History of aortic valve re-intervention (including percutaneous paravalvular leak closure)
研究组 & 干预措施
Intra-annular
Patients with an intra-annular Sapien TAVI prosthesis
干预措施: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) (Diagnostic Test)
Supra-annular
Patients with a supra-annular CoreValve Evolut TAVI prosthesis
干预措施: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) (Diagnostic Test)
结局指标
主要结局
Subclinical Leaflet Thrombosis
时间窗: 5 years after TAVI
Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Quantified bioprosthetic micro-calcification activity
时间窗: 5 years after TAVI
18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Valve dysfunction
时间窗: 5 years after TAVI
Transvalvular gradients assessed with transthoracic echocardiography
次要结局
未报告次要终点
研究者
Jurriën M. ten Berg, MD, PhD
MD, PhD, MSc
St. Antonius Hospital
