跳至主要内容
临床试验/NCT06896227
NCT06896227招募中不适用

Transcatheter Aortic Valve Implantation (TAVR): the Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Transvalvular gradients

研究概览

简要总结

The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries.

The main questions it aims to answer are:

  1. Does the cardiac magnetic resonance imaging and the echocardiography imaging provide an equivalent alternative to the computer tomography which is the state of the art in evaluating commissural alignment?
  2. What effect does the position of the valve on the annular level have, especially its symmetrical and commissural position, on valvular and aortic blood flow characteristics?
  3. What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?

详细描述

Coming from a treatment option only for a high-risk cohort of elderly patients, transcatheter aortic valve replacement (TAVR) has become a safe and effective therapeutic approach for most patients with severe aortic valve stenosis (AS). Therefore, current guidelines recommend TAVR in patients from the age of 75 and even low surgical risk. Especially with the increasingly younger patient clientele, lifetime management is of utmost importance. Lifetime management includes, for example:

  • Preserving coronary access after TAVR
  • "Durability" of the new valve.
  • Prevention of paravalvular leakage
  • Prevention of atrioventricular blocks, which may necessitate a pacemaker.

The first two factors are particularly important and have therefore become the focus of the work.

Relating to this, the investigators would like to investigate three points:

  1. Coronary access after TAVR is an important aspect for especially younger patients with longer life expectancy. The manufacturers try to address this task by offering techniques, which should help to orientate the novel commissures of the TAVR-valve within the native commissures of the diseased valve. Until now, the commissural alignment (CA) or misalignment (misCA) can only be depicted by post-TAVR cardiac computer tomography (CT) or selective coronary angiography, coming along with additional radiation and contrast medium exposure. Cardiovascular magnetic resonance imaging (CMRI) as well as transoesophageal echocardiography (TEE) may be alternative diagnostic options but have not been tested so far.
  2. Transvalvular blood flow characteristics depending on the position of TAVR-prosthesis at the annular level may play a significant role concerning prothesis durability. However, it is unknown whether an asymmetric position or the presence of a CA may alter flow profile and therefore cause secondary endothelial stress leading to long term damage. With transthoracic echocardiography (TTE), TEE and CMRI the investigators would like to characterize flow patterns depending on symmetric vs. asymmetric valve position and CA vs. misCA.
  3. It is not known what influence the TAVR position, more precisely a symmetric implantation and the presence of a CA, has on coronary flow and clinical outcomes. To investigate this, the investigators will record coronary flow in TEE and CMR after the implantation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).

排除标准

  • Any access route other than transfemoral.
  • Valve-in-valve procedures.
  • History of prior bioprosthetic valve implantation.
  • Presence of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) system.
  • Diagnosis of liver cirrhosis.
  • Esophageal disorders, including but not limited to esophageal varices.
  • Thrombocytopenia or coagulation disorders.
  • Any medical or psychiatric condition (e.g., dementia, alcoholism, or substance abuse) that may impair the ability to provide informed consent or interfere with study procedures, including follow-up visits.

结局指标

主要结局

Transvalvular gradients

时间窗: baseline + day 1

by Transthoracic echocardiography

Presence of a commissural alignment

时间窗: Day 1

by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

Presence of symmetrical position

时间窗: Day 1

by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

Effective orifice area (EOA)

时间窗: baseline + day 1

by Transthoracic echocardiography

Doppler velocity index

时间窗: baseline + day 1

by Transthoracic echocardiography

Paravalvular leakage

时间窗: Day 1

by transoesophageal echocardiograpy

Turbulent flow

时间窗: baseline + day 1

by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

Pressure recovery

时间窗: Day 1

by cardiac magnetic resonance imaging

Energy loss coefficient

时间窗: Day 1

by transoesophageal echocardiograpy

global coronary flow reserve

时间窗: Day 1

by cardiac magnetic resonance imaging

Peak velocity

时间窗: Day 1

by cardiac magnetic resonance imaging

Wall sheer stress

时间窗: Day 1

by cardiac magnetic resonance imaging

Flow displacement

时间窗: Day 1

by cardiac magnetic resonance imaging

aortic area

时间窗: Day 1

by cardiac magnetic resonance imaging

volumen

时间窗: Day 1

by cardiac magnetic resonance imaging

LV-Function

时间窗: baseline + day 1

by transthoracic echocardiograpy and cardiac magnetic resonance imaging

RV-Function

时间窗: baseline + day 1

by transthoracic echocardiograpy and cardiac magnetic resonance imaging

Strain

时间窗: Day 1

by transthoracic echocardiograpy

次要结局

未报告次要终点

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (2)

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