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| Name | Class |
|---|---|
| Heart Center Leipzig - University Hospital | OTHER |
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The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.
Prospective, single center, open-label study to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary physiology | Other | Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assession of complete coronary physiology | Procedure | Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI | Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio. The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI). | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy by considering FFR values of >0.80 as normal | diagnostic accuracy (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering FFR values of >0.80 as normal | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Majunke, Dr. | Contact | +49 341 865 1428 | nicolas.majunke@medizin.uni-leipzig.de | |
| Mohamed Abdel-Wahab, Prof. Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Majunke, Dr. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Study Chair |
| Robin Gohmann, Dr. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology | Recruiting | Leipzig | 04289 | Germany |
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Prospective, single center, open-label
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| Diagnostic accuracy by considering RFR values of >0.89 as normal |
diagnostic accuracy (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering RFR values of >0.89 as normal |
| 6 Months |
| Mohamed Abdel-Wahab, Prof. Dr. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Principal Investigator |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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