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临床试验/NCT04359030
NCT04359030已完成不适用

In Vivo Calcium Score Measurement After Freestyle Full Root Replacement in Young Adults

Ziekenhuis Oost-Limburg1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Quantification of aortic leaflet Calcium-score in FS and PM valve

研究概览

简要总结

The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.

详细描述

A recent update of the American Hear Association and American College of Cardiology Guidelines for the Management of Patients With Valvular Heart Disease1 recommended that for patients between 50 and 70 years of age, it is reasonable to the choice of either a mechanical or bioprosthetic valve; the threshold for biological valves continues to decrease and more younger adults will receive this kind of prosthesis. However the best biological option for these patients is still a matter of debate. Stented bio-prosthesis is the most common choice. However, the predicted 15-year risk of needing reoperation because of structural deterioration is 22% for patients 50 years of age2.

In the late 80's stentless valve as the Medtronic Freestyle (FS) has been introduced with the hope that it may provide physiological flow in the aortic root, sinuses, and coronary orifices and a low risk of thromboembolism. Several randomized study and meta-analysis demonstrated improved hemodynamic, a larger orifice area and a midterm survival advantage of stentless aortic valve compared to stented aortic valve replacement3, 4. The FS valve is believed to provide greater durability and superior hemodynamic performance due to the low mechanical stress on the leaflet tissues. The failure mode of the FS is thought to be mostly calcification of the aorta wall and cusp tears because collagen degradation5. This phenomenon is inflammation mediated process.

Aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.

Between 2007 and 2017, among patients younger than 60 years of age, 51 patients underwent a full root replacement with a FS and 49 received a Perimount Magna Ease prosthesis. Those patients will undergo a 3D CT scan. The group of the patient with PM will be matched in function of age and interval of follow-up with the FS group.

A transthoracic echocardiogram will be performed to check residual valve insufficiency and trans-valvular gradients. A cardiopulmonary exercise test ( with extraction of maximal oxygen consumption ) combined with a trans thoracic echocardiography (stress echocardiography) will be performed to evaluate the patients exercise capacity and its influence on the cardiac and valve function.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form
  • Patients treated with FS or PM
  • Age less than 60 at the moment of the implant

排除标准

  • Kidney failure or contrast allergy
  • Previous endocarditis and aortic dissection
  • Pregnancy or lactation

结局指标

主要结局

Quantification of aortic leaflet Calcium-score in FS and PM valve

时间窗: 3 years

The Agatston score. The score is calculated using a weighted value assigned to the highest density of calcification in a given coronary artery. The density is measured in Hounsfield units (HU), and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater. The higher the score the more the calcification.

次要结局

  • Echocardiographic function of the aortic valve at rest and during exercise: transvalvular mean and peak gradient(3 years)
  • Echocardiographic function of the aortic valve at rest and during exercise: Valve regurgitation(3 years)
  • Exercise capacity: New York Heart Association class(3 years)
  • Exercise capacity: maximum oxygen consumption(3 years)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Pettinari

Principal Investigator

Ziekenhuis Oost-Limburg

研究点 (1)

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