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NCT Number: NCT06896227

TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

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?

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Key information

Conditions

Transcatheter Aortic Valve Replacement Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Commissural Alignment Commissural Misalignment Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Durability Prosthesis Failure Prothesis Positioning Symmetry Transcatheter Aortic Valve Implantation Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location status: Recruiting

Location contact

Ayse Sedef Ceylan, Dr. med.

PRINCIPAL_INVESTIGATOR

Kathrin Klein, MD

CONTACT

[email protected]

0211 81 08252

Tobias Zeus, Prof.

CONTACT

[email protected]

0211 81 18801

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement.

Other names: Transoesophageal echocardiography, cardiac magnetic resonance imaging

Primary outcomes

  1. Presence of a commissural alignment

    Time frame: Day 1

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

  2. Presence of symmetrical position

    Time frame: Day 1

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

  3. Transvalvular gradients

    Time frame: baseline + day 1

    by Transthoracic echocardiography

  4. Effective orifice area (EOA)

    Time frame: baseline + day 1

    by Transthoracic echocardiography

  5. Doppler velocity index

    Time frame: baseline + day 1

    by Transthoracic echocardiography

  6. Paravalvular leakage

    Time frame: Day 1

    by transoesophageal echocardiograpy

  7. Turbulent flow

    Time frame: baseline + day 1

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

  8. Pressure recovery

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  9. Energy loss coefficient

    Time frame: Day 1

    by transoesophageal echocardiograpy

  10. global coronary flow reserve

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  11. Peak velocity

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  12. Wall sheer stress

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  13. Flow displacement

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  14. aortic area

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  15. volumen

    Time frame: Day 1

    by cardiac magnetic resonance imaging

  16. LV-Function

    Time frame: baseline + day 1

    by transthoracic echocardiograpy and cardiac magnetic resonance imaging

  17. RV-Function

    Time frame: baseline + day 1

    by transthoracic echocardiograpy and cardiac magnetic resonance imaging

  18. Strain

    Time frame: Day 1

    by transthoracic echocardiograpy

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrin Klein, Dr. med.

CONTACT

[email protected]

0211 81 08252

Tobias Zeus, Prof

CONTACT

[email protected]

0211 81 18800

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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