Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
Assession of complete coronary physiology: Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age \>18 years
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
* Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
* CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).
* Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)
* Eligible for coronary CT-angiography and functional assessment (CT-FFR)
Exclusion Criteria:
* Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
* Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
* Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
* Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
* Contraindication to adenosine (e.g. bronchial asthma)
* Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR \<30 ml/min)
* Presence of cardiogenic shock
* Participation in another interventional study involving the left heart or coronary arteries
Primary outcome measure(s)
Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI — 6 Months 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).
Trial sites (1)
Facility
City
Region
Status
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
Leipzig
Germany
Recruiting
More Helios Health Institute GmbH trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.