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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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transthoracic echocardiography | Diagnostic Test | Each study patient will undergo transthoracic echocardiography, transesophageal echocardiography, and cardiac magnetic resonance imaging following transcatheter aortic valve replacement. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
- Patients who have undergone transfemoral transcatheter aortic valve replacement (TAVR).
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Zeus, Prof | Contact | 0211 81 18800 | zeus@med.uni-duesseldorf.de | |
| Kathrin Klein, Dr. med. | Contact | 0211 81 08252 | kathrin.klein@med-uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf | Recruiting | Düsseldorf | 40225 | Germany |
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|
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 |
| Kathrin Klein, Dr. med. | Division of Cardiology, Pulmonary Disease and Vascular Medicine | Study Director |
| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D017548 | Echocardiography, Transesophageal |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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