Actively Recruiting
Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prosthesis Positioning on Valvular and Coronary Hemodynamics
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-03-26
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand how the positioning of a transcatheter aortic valve replacement (TAVR) prosthesis affects blood flow in the heart and coronary arteries. The study focuses on whether cardiac magnetic resonance imaging (CMRI) and echocardiography can offer alternatives to computer tomography for evaluating valve alignment. It also investigates how the valve's position, especially its symmetry and commissural alignment, impacts blood flow through the valve and aorta, as well as coronary flow after TAVR. Participants in this study will have undergone transfemoral TAVR and will receive diagnostic imaging assessments including transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and cardiac magnetic resonance imaging. These imaging tests will be used to evaluate valve positioning, blood flow characteristics, and coronary flow. The study examines the presence of commissural alignment and symmetry, as well as measures like transvalvular gradients, effective orifice area, paravalvular leakage, turbulent flow, coronary flow reserve, and heart function. Throughout the study, participants will undergo imaging assessments shortly after TAVR to collect detailed data on valve and coronary blood flow. Researchers will monitor various parameters such as pressure recovery, energy loss, wall shear stress, and ventricular function. The findings aim to guide future improvements in valve implantation techniques to enhance valve durability and coronary access. The study is led by Heinrich-Heine University, Duesseldorf, and involves no masking or placebo control.
CONDITIONS
Brief Title
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement to assess valve position and coronary flow.
1 visit (in-person) after TAVR
Duration - Up to several months following diagnostic evaluation
Participants are monitored over time to evaluate valve durability and coronary flow characteristics.
Additional visits may occur depending on clinical follow-up
Trial Site Locations
Total: 1 location
1
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
Research Team
T
Tobias Zeus, Prof
K
Kathrin Klein, Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here