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

Medical University Innsbruck

Status: Enrolling

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

Treatments: Diagnostic Test: PCD-CT-Guided Diagnostic Strategy; Diagnostic Test: Standard Invasive Coronary Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT07107568

1124/2025

Details and patient eligibility

About

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.

Full description

The goal of this randomized, multicenter trial is to assess the safety and efficacy of a non-invasive diagnostic strategy using photon-counting detector computed tomography (PCD-CT) for the assessment of coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR), compared to the current standard of care using invasive coronary angiography (ICA).

The trial evaluates the hypothesis that a PCD-CT-guided strategy is non-inferior to routine ICA with respect to the risk of major adverse cardiovascular events (MACE) at 12 months. MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

PCD-CT-Guided Diagnostic Strategy

Experimental group

Description:

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.

Treatment:

Diagnostic Test: PCD-CT-Guided Diagnostic Strategy

Standard Invasive Coronary Angiography

Active Comparator group

Description:

Participants randomized to this arm will undergo routine invasive coronary angiography (ICA) as the standard of care for pre-TAVR assessment of coronary artery disease.

Treatment:

Diagnostic Test: Standard Invasive Coronary Angiography