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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
View on ClinicalTrials.gov →
NCT07107568
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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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorMedical University Innsbruck
Started2025-08-14
Est. completion2029-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07107568