MedTrace Logo

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

NCT06896227 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-26

No results posted yet for this study

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?

Conditions

  • Transcatheter Aortic Valve Replacement
  • Transcatheter Aortic Valve Implantation
  • Commissural Alignment
  • Commissural Misalignment
  • Symmetry
  • Prothesis Positioning
  • Prosthesis Durability
  • Aortic Valve Stenosis
  • Aortic Valve Disease

Interventions

DIAGNOSTIC_TEST

transthoracic echocardiography

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

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Malte Kelm, Prof. · Division of Cardiology, Pulmonary Disease and Vascular Medicine

  • Tobias Zeus, Prof. · Division of Cardiology, Pulmonary Disease and Vascular Medicine

  • Kathrin Klein, Dr. med. · Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2025-09-01
Completion
2025-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896227 on ClinicalTrials.gov