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临床试验/NCT05758662
NCT05758662招募中不适用

The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration

St. Antonius Hospital5 个研究点 分布在 3 个国家目标入组 180 人开始时间: 2023年11月16日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jurriën M. ten Berg, MD, PhD

MD, PhD, MSc

St. Antonius Hospital

研究点 (5)

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