Actively Recruiting
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
Led by Helios Health Institute GmbH · Updated on 2024-11-25
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
H
Helios Health Institute GmbH
Lead Sponsor
H
Heart Center Leipzig - University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
Leipzig, Germany, 04289
Actively Recruiting
Research Team
N
Nicolas Majunke, Dr.
CONTACT
M
Mohamed Abdel-Wahab, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here