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

Recruiting now · Not applicable

Conditions studied: Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment, Symmetry, Prothesis Positioning, Prosthesis Durability, Aortic Valve Stenosis, Aortic Valve Disease

In brief

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?

Key facts

Study ID

NCT06896227

Run by

Heinrich-Heine University, Duesseldorf

People needed

100

Starts

2024-10-22

Expected to finish

2025-12-31

Last updated by the study team

2025-03-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf — Düsseldorf, Germany (enrolling)

Full record on ClinicalTrials.gov

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