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Clinical Trials in Germany / NCT05133843
Recruiting Not applicable

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

NCT05133843 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2021-09-29
Last updated
2024-11-25

Condition(s) studied

Coronary Artery StenosisTranscatheter Aortic Valve Implantation

Investigational drug(s) / intervention(s)

Assession of complete coronary physiology

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)

Trial sites (1)

FacilityCityRegionStatus
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology Leipzig Germany Recruiting

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Other trials for the same condition

Official registry record

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.

View NCT05133843 on ClinicalTrials.gov ↗ ← All trials in Germany