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 1. compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI 2. correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI 3. correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
Leipzig, Germany
RECRUITINGComparison 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).
Time frame: 6 Months
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
Time frame: 6 Months
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
Time frame: 6 Months
Mohamed Abdel-Wahab, Prof. Dr.
CONTACT
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