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Recruiting NCT07107568

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

Trial Parameters

Condition Aortic Valve Stenosis and Insufficiency
Sponsor Medical University Innsbruck
Study Type INTERVENTIONAL
Phase N/A
Enrollment 700
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-08-14
Completion 2029-12-31
Interventions
Standard Invasive Coronary AngiographyPCD-CT-Guided Diagnostic Strategy

Brief 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 Criteria

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

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