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