ClinicalTrials.gg
Sign In
RecruitingNCT06896227Updated Mar 26, 2025

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

An interventional study of transthoracic echocardiography in Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation and Commissural Alignment, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Oct 2024, registered Mar 2025).
  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
01

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?
Read the detailed description

Coming from a treatment option only for a high-risk cohort of elderly patients, transcatheter aortic valve replacement (TAVR) has become a safe and effective therapeutic approach for most patients with severe aortic valve stenosis (AS). Therefore, current guidelines recommend TAVR in patients from the age of 75 and even low surgical risk. Especially with the increasingly younger patient clientele, lifetime management is of utmost importance. Lifetime management includes, for example:

  • Preserving coronary access after TAVR
  • "Durability" of the new valve.
  • Prevention of paravalvular leakage
  • Prevention of atrioventricular blocks, which may necessitate a pacemaker.

The first two factors are particularly important and have therefore become the focus of the work.

Relating to this, the investigators would like to investigate three points:

  1. Coronary access after TAVR is an important aspect for especially younger patients with longer life expectancy. The manufacturers try to address this task by offering techniques, which should help to orientate the novel commissures of the TAVR-valve within the native commissures of the diseased valve. Until now, the commissural alignment (CA) or misalignment (misCA) can only be depicted by post-TAVR cardiac computer tomography (CT) or selective coronary angiography, coming along with additional radiation and contrast medium exposure. Cardiovascular magnetic resonance imaging (CMRI) as well as transoesophageal echocardiography (TEE) may be alternative diagnostic options but have not been tested so far.
  2. Transvalvular blood flow characteristics depending on the position of TAVR-prosthesis at the annular level may play a significant role concerning prothesis durability. However, it is unknown whether an asymmetric position or the presence of a CA may alter flow profile and therefore cause secondary endothelial stress leading to long term damage. With transthoracic echocardiography (TTE), TEE and CMRI the investigators would like to characterize flow patterns depending on symmetric vs. asymmetric valve position and CA vs. misCA.
  3. It is not known what influence the TAVR position, more precisely a symmetric implantation and the presence of a CA, has on coronary flow and clinical outcomes. To investigate this, the investigators will record coronary flow in TEE and CMR after the implantation.

The results could be used in the future to detect CA or misCA and thereby evaluate and improve implantation techniques without harming the patient. Furthermore, if the investigators can identify advantages in symmetrically implanted TAVR with CA in terms of valve and coronary flow, techniques can be developed that target both symmetric and CA.

02

Conditions studied

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

Keywords

  • TAVR
  • TAVI
  • Commissural alignment
  • Symmetry
  • Prothesis positioning
  • cMRI
  • 4D Flow
  • TEE
03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 100 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.

Browse Heinrich-Heine University, Duesseldorf studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • 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 or interfere with study procedures, including follow-up visits.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    TTE, TEE and MRI after TAVR

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

    Diagnostic Test: transthoracic echocardiography

Interventions

  • Diagnostic testtransthoracic echocardiography

    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

06

What researchers measure

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

  5. Doppler velocity index

    by Transthoracic echocardiography

    Time frame: baseline + day 1

  6. Paravalvular leakage

    by transoesophageal echocardiograpy

    Time frame: Day 1

  7. Turbulent flow

    by transoesophageal echocardiograpy and cardiac magnetic resonance imaging

    Time frame: baseline + day 1

  8. Pressure recovery

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  9. Energy loss coefficient

    by transoesophageal echocardiograpy

    Time frame: Day 1

  10. global coronary flow reserve

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  11. Peak velocity

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  12. Wall sheer stress

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  13. Flow displacement

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  14. aortic area

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  15. volumen

    by cardiac magnetic resonance imaging

    Time frame: Day 1

  16. LV-Function

    by transthoracic echocardiograpy and cardiac magnetic resonance imaging

    Time frame: baseline + day 1

  17. RV-Function

    by transthoracic echocardiograpy and cardiac magnetic resonance imaging

    Time frame: baseline + day 1

  18. Strain

    by transthoracic echocardiograpy

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Sep 2025, 10 months after the start.

Of 48 non-industry interventional studies with no phase under Prosthesis Failure, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 10 months is below that.

Counting every sponsor, half of 50 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2025
First posted
Mar 26, 2025
StartActual
Oct 22, 2024
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 31, 2025
Last update
Mar 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06896227
Lead sponsor
Heinrich-Heine University, Duesseldorf
Responsible party
Sponsor
First posted
Mar 26, 2025
Start date
Oct 22, 2024
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 26, 2025

Study contacts

Tobias Zeus, Prof
Contact
zeus@med.uni-duesseldorf.de
0211 81 18800
Kathrin Klein, Dr. med.
Contact
kathrin.klein@med-uni-duesseldorf.de
0211 81 08252
Malte Kelm, Prof.
study chair · Division of Cardiology, Pulmonary Disease and Vascular Medicine
Tobias Zeus, Prof.
study director · Division of Cardiology, Pulmonary Disease and Vascular Medicine
Kathrin Klein, Dr. med.
study director · Division of Cardiology, Pulmonary Disease and Vascular Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prosthesis Failure →

Other studies from this sponsor

Heinrich-Heine University, Duesseldorf →

Start the discussion