transthoracic echocardiography: Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement.
Study summary
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?
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria
\- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).
Exclusion Criteria
* 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.
Primary outcome measure(s)
Presence of a commissural alignment — Day 1 by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Presence of symmetrical position — Day 1 by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Transvalvular gradients — baseline + day 1 by Transthoracic echocardiography
Effective orifice area (EOA) — baseline + day 1 by Transthoracic echocardiography
Doppler velocity index — baseline + day 1 by Transthoracic echocardiography
Paravalvular leakage — Day 1 by transoesophageal echocardiograpy
Turbulent flow — baseline + day 1 by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Pressure recovery — Day 1 by cardiac magnetic resonance imaging
Energy loss coefficient — Day 1 by transoesophageal echocardiograpy
global coronary flow reserve — Day 1 by cardiac magnetic resonance imaging
Peak velocity — Day 1 by cardiac magnetic resonance imaging
Wall sheer stress — Day 1 by cardiac magnetic resonance imaging
Flow displacement — Day 1 by cardiac magnetic resonance imaging
aortic area — Day 1 by cardiac magnetic resonance imaging
volumen — Day 1 by cardiac magnetic resonance imaging
LV-Function — baseline + day 1 by transthoracic echocardiograpy and cardiac magnetic resonance imaging
RV-Function — baseline + day 1 by transthoracic echocardiograpy and cardiac magnetic resonance imaging
Strain — Day 1 by transthoracic echocardiograpy
Trial sites (1)
Facility
City
Region
Status
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf
Germany
Recruiting
More Heinrich-Heine University, Duesseldorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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