NCT06896227

Brief 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. 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. 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. 3.What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 26, 2025

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

March 13, 2025

Last Update Submit

March 19, 2025

Conditions

Transcatheter Aortic Valve ReplacementTranscatheter Aortic Valve ImplantationCommissural AlignmentCommissural MisalignmentSymmetryProthesis PositioningProsthesis DurabilityAortic Valve StenosisAortic Valve Disease

Keywords

TAVRTAVICommissural alignmentSymmetryProthesis positioningcMRI4D FlowTEE

Outcome Measures

Primary Outcomes (18)

  • Presence of a commissural alignment

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

    Day 1

  • Presence of symmetrical position

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

    Day 1

  • Transvalvular gradients

    by Transthoracic echocardiography

    baseline + day 1

  • Effective orifice area (EOA)

    by Transthoracic echocardiography

    baseline + day 1

  • Doppler velocity index

    by Transthoracic echocardiography

    baseline + day 1

  • Paravalvular leakage

    by transoesophageal echocardiograpy

    Day 1

  • Turbulent flow

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

    baseline + day 1

  • Pressure recovery

    by cardiac magnetic resonance imaging

    Day 1

  • Energy loss coefficient

    by transoesophageal echocardiograpy

    Day 1

  • global coronary flow reserve

    by cardiac magnetic resonance imaging

    Day 1

  • Peak velocity

    by cardiac magnetic resonance imaging

    Day 1

  • Wall sheer stress

    by cardiac magnetic resonance imaging

    Day 1

  • Flow displacement

    by cardiac magnetic resonance imaging

    Day 1

  • aortic area

    by cardiac magnetic resonance imaging

    Day 1

  • volumen

    by cardiac magnetic resonance imaging

    Day 1

  • LV-Function

    by transthoracic echocardiograpy and cardiac magnetic resonance imaging

    baseline + day 1

  • RV-Function

    by transthoracic echocardiograpy and cardiac magnetic resonance imaging

    baseline + day 1

  • Strain

    by transthoracic echocardiograpy

    Day 1

Study Arms (1)

TTE, TEE and MRI after TAVR

OTHER

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

Diagnostic Test: transthoracic echocardiography

Interventions

transthoracic echocardiographyDIAGNOSTIC_TEST

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

Also known as: Transoesophageal echocardiography, cardiac magnetic resonance imaging
TTE, TEE and MRI after TAVR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Prosthesis FailureAortic Valve StenosisAortic Valve Disease

Interventions

EchocardiographyEchocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Malte Kelm, Prof.

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    STUDY CHAIR

  • Tobias Zeus, Prof.

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    STUDY DIRECTOR

  • Kathrin Klein, Dr. med.

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    STUDY DIRECTOR

Central Study Contacts

Tobias Zeus, Prof

CONTACT

0211 81 18800zeus@med.uni-duesseldorf.de

Kathrin Klein, Dr. med.

CONTACT

0211 81 08252kathrin.klein@med-uni-duesseldorf.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 26, 2025

Study Start

October 22, 2024

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

March 26, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)