Transcatheter Aortic Valve ReplacementNCT06896227
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
A study testing transthoracic echocardiography in people with Transcatheter Aortic Valve Replacement and Transcatheter Aortic Valve Implantation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment
- What is being tested?
- transthoracic echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 22 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf, 40225
Tobias Zeus, Prof., 0211 81 18801, zeus@med.uni-duesseldorf.de
Kathrin Klein, MD, 0211 81 08252, kathrin.klein@med.uni-duesseldorf.de
About this study
Official title: Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
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:
- 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?
- 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?
- 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:
- 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.
- 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.
- 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.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment, Symmetry, Prothesis Positioning
- Being tested
- transthoracic echocardiography
- Keywords
- TAVR, TAVI, Commissural alignment, Symmetry, Prothesis positioning, cMRI, 4D Flow, TEE
- Medical subject headings
- Prosthesis Failure, Aortic Valve Stenosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyDiagnostic test
Also called Transoesophageal echocardiography, cardiac magnetic resonance imaging
Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a commissural alignment
by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Measured: Day 1
Presence of symmetrical position
by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Measured: Day 1
Transvalvular gradients
by Transthoracic echocardiography
Measured: baseline + day 1
Effective orifice area (EOA)
by Transthoracic echocardiography
Measured: baseline + day 1
Doppler velocity index
by Transthoracic echocardiography
Measured: baseline + day 1
Paravalvular leakage
by transoesophageal echocardiograpy
Measured: Day 1
Turbulent flow
by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Measured: baseline + day 1
Pressure recovery
by cardiac magnetic resonance imaging
Measured: Day 1
Energy loss coefficient
by transoesophageal echocardiograpy
Measured: Day 1
global coronary flow reserve
by cardiac magnetic resonance imaging
Measured: Day 1
Peak velocity
by cardiac magnetic resonance imaging
Measured: Day 1
Wall sheer stress
by cardiac magnetic resonance imaging
Measured: Day 1
Flow displacement
by cardiac magnetic resonance imaging
Measured: Day 1
aortic area
by cardiac magnetic resonance imaging
Measured: Day 1
volumen
by cardiac magnetic resonance imaging
Measured: Day 1
LV-Function
by transthoracic echocardiograpy and cardiac magnetic resonance imaging
Measured: baseline + day 1
RV-Function
by transthoracic echocardiograpy and cardiac magnetic resonance imaging
Measured: baseline + day 1
Strain
by transthoracic echocardiograpy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start22 Oct 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Division of Cardiology, Pulmonary Disease and Vascular MedicineTobias Zeus, Prof., Study director, Division of Cardiology, Pulmonary Disease and Vascular MedicineKathrin Klein, Dr. med., Study director, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896227
- Sponsor's protocol ID
- CaS
- Status last verified
- Oct 2024
- First submitted
- 13 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Implantation (TAVR): The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
- ClinicalTrials.gov ID
- NCT06896227
- Acronym / sponsor ID
- CaS
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment, Symmetry, Prothesis Positioning
- Keywords
- TAVR, TAVI, Commissural alignment, Symmetry, Prothesis positioning, cMRI, 4D Flow, TEE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- What is the influence of symmetrical position and the presence of a commissural alignment on the coronary flow after transcatheter aortic valve replacement?
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTE, TEE and MRI after TAVR | Other | Diagnostic Test: transthoracic echocardiographyEach study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic echocardiographyAlso: Transoesophageal echocardiography, cardiac magnetic resonance imagingEach study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement. | Diagnostic test | TTE, TEE and MRI after TAVR |
Primary outcome
Presence of a commissural alignment
Time frame: Day 1
by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Presence of symmetrical position
Time frame: Day 1
by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Transvalvular gradients
Time frame: baseline + day 1
by Transthoracic echocardiography
Effective orifice area (EOA)
Time frame: baseline + day 1
by Transthoracic echocardiography
Doppler velocity index
Time frame: baseline + day 1
by Transthoracic echocardiography
Paravalvular leakage
Time frame: Day 1
by transoesophageal echocardiograpy
Turbulent flow
Time frame: baseline + day 1
by transoesophageal echocardiograpy and cardiac magnetic resonance imaging
Pressure recovery
Time frame: Day 1
by cardiac magnetic resonance imaging
Energy loss coefficient
Time frame: Day 1
by transoesophageal echocardiograpy
global coronary flow reserve
Time frame: Day 1
by cardiac magnetic resonance imaging
Peak velocity
Time frame: Day 1
by cardiac magnetic resonance imaging
Wall sheer stress
Time frame: Day 1
by cardiac magnetic resonance imaging
Flow displacement
Time frame: Day 1
by cardiac magnetic resonance imaging
aortic area
Time frame: Day 1
by cardiac magnetic resonance imaging
volumen
Time frame: Day 1
by cardiac magnetic resonance imaging
LV-Function
Time frame: baseline + day 1
by transthoracic echocardiograpy and cardiac magnetic resonance imaging
RV-Function
Time frame: baseline + day 1
by transthoracic echocardiograpy and cardiac magnetic resonance imaging
Strain
Time frame: Day 1
by transthoracic echocardiograpy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transthoracic echocardiography in people with Transcatheter Aortic Valve Replacement and Transcatheter Aortic Valve Implantation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Zeus, Prof (0211 81 18800, zeus@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a commissural alignment (time frame: Day 1). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.