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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Medical University Innsbruck • ClinicalTrials.gov ID: NCT07107568

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Standard Invasive Coronary Angiography (Diagnostic test)
    Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
  • PCD-CT-Guided Diagnostic Strategy (Diagnostic test)
    Participants randomized to this arm will undergo coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT). Invasive coronary angiography (ICA) will only be performed if PCD-CT shows significant CAD, defined as ≥70% diameter stenosis in vessels ≥2.5 mm or ≥50% in the left main artery.

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

Conditions

Aortic Valve Stenosis and Insufficiency Coronary Artery Disease(CAD) Transcatheter Aortic Valve Replacement (TAVR)

Locations

  • Medical University of Innsbruck — Innsbruck, Austria
  • Department of Internal Medicine II, Cardiology and Intensive Care Medicine, Klinikum Wels-Grieskirchen — Wels, Austria
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record