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Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial

RECRUITINGN/ASponsored by Medical University Innsbruck
Actively Recruiting
PhaseN/A
SponsorMedical University Innsbruck
Started2025-08-14
Est. completion2029-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age ≥ 18 years
* Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines
* TAVR candidate
* Written informed consent

Exclusion Criteria:

* Cardiogenic shock at presentation (e.g., emergency indication for TAVR)
* Severe renal impairment with an estimated glomerular filtration rate of \<30 mL/min/1.73 m²
* Life expectancy \<1 year due to other severe non-cardiac disease (e.g., malignancy)
* Pregnancy

Conditions4

Aortic Valve Stenosis and InsufficiencyCoronary Artery Disease (CAD)Heart DiseaseTranscatheter Aortic Valve Replacement (TAVR)

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