Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis

Launched by HELIOS HEALTH INSTITUTE GMBH · Nov 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a procedure called Transcatheter Aortic Valve Implantation (TAVI) affects blood flow in the coronary arteries of patients who have both severe aortic valve stenosis and some narrowing in their coronary arteries. The researchers want to look at various tests that measure how well blood is flowing through the heart before and six months after the TAVI procedure. This will help them understand how TAVI impacts the heart's blood supply over time.

To be eligible for the trial, participants need to be over 18 years old and have severe symptomatic aortic stenosis, which means their heart valve isn’t working well and is causing symptoms. They should also have some narrowing in their coronary arteries that needs further assessment. Participants will undergo specific heart tests, including non-invasive scans and possibly more detailed procedures, to evaluate blood flow and artery function. It's important to know that individuals with certain severe heart conditions or those who have had specific heart surgeries may not qualify for this study.

Gender

ALL

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