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
| NCT ID | NCT05133843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helios Health Institute GmbH |
| Condition | Coronary Artery Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2024-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2021-09-29 with a primary completion date of 2024-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Nicolas Majunke, Dr.
STUDY CHAIR
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Frequently Asked Questions
Who can join the NCT05133843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05133843 currently recruiting?
Yes, NCT05133843 is actively recruiting participants. Contact the research team at nicolas.majunke@medizin.uni-leipzig.de for enrollment information.
Where is the NCT05133843 trial being conducted?
This trial is being conducted at Leipzig, Germany.
Who is sponsoring the NCT05133843 clinical trial?
NCT05133843 is sponsored by Helios Health Institute GmbH. The principal investigator is Nicolas Majunke, Dr. at Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology. The trial plans to enroll 50 participants.