Clinical trial NCT05133843: Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
Official title: Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Stenosis
Transcatheter Aortic Valve Implantation
Keywords: Coronary Artery Stenosis
transcatheter aortic valve implantation
coronary physiology
coronary blood flow
coronary microcirculatory function
non-invasive CT-FFR
fractional flow reserve
resting full cycle ratio
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2021-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single center, open-label
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
timeFrame: 6 Months
Secondary outcomes:
measure: Diagnostic accuracy by considering FFR values of >0.80 as normal
timeFrame: 6 Months
measure: Diagnostic accuracy by considering RFR values of >0.89 as normal
timeFrame: 6 Months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Nicolas Majunke, Dr.
role: STUDY_CHAIR
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Robin Gohmann, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Mohamed Abdel-Wahab, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: