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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHeinrich-Heine University, Duesseldorf

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • transthoracic echocardiography

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: TTE, TEE and MRI after TAVROther 1 intervention

Trial outcomes

Primary outcomes

1

Presence of a commissural alignment

by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

Time frame
Day 1
2

Presence of symmetrical position

by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

Time frame
Day 1
3

Transvalvular gradients

by Transthoracic echocardiography

Time frame
baseline + day 1
4

Effective orifice area (EOA)

by Transthoracic echocardiography

Time frame
baseline + day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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