Actively Recruiting

Phase Not Applicable
All Genders
ID06896227

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

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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

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