TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transthoracic echocardiography.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
Overview
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?
Detailed description
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.
The results could be used in the future to detect CA or misCA and thereby evaluate and improve implantation techniques without harming the patient. Furthermore, if the investigators can identify advantages in symmetrically implanted TAVR with CA in terms of valve and coronary flow, techniques can be developed that target both symmetric and CA.
Interventions
- Diagnostic test transthoracic echocardiography
Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement.
Primary outcome measures
- Presence of a commissural alignment [Time frame: Day 1]
- Presence of symmetrical position [Time frame: Day 1]
- Transvalvular gradients [Time frame: baseline + day 1]
- Effective orifice area (EOA) [Time frame: baseline + day 1]
- Doppler velocity index [Time frame: baseline + day 1]
- Paravalvular leakage [Time frame: Day 1]
- Turbulent flow [Time frame: baseline + day 1]
- Pressure recovery [Time frame: Day 1]
- Energy loss coefficient [Time frame: Day 1]
- global coronary flow reserve [Time frame: Day 1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 1 center
- Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Due — Düsseldorf
Identifiers
NCT: NCT06896227 · CaS