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RecruitingNot ApplicableNCT06896227

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

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

Sponsor

Heinrich-Heine University, Duesseldorf

Enrollment

100 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Valve DiseaseProsthesis DurabilityAortic Valve StenosisTranscatheter Aortic Valve ReplacementTranscatheter Aortic Valve ImplantationCommissural AlignmentCommissural MisalignmentSymmetryProthesis Positioning

Summary

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?

Eligibility

Inclusion Criteria1

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

Exclusion Criteria8

  • 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.

Interventions

DIAGNOSTIC_TESTtransthoracic echocardiography

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

Locations(1)

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

Düsseldorf, Germany

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NCT06896227

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