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NCT Number: NCT07107568

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

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.

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Key information

Conditions

Aortic Valve Stenosis and Insufficiency Aortic Valve Disease Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Disease(CAD) Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Transcatheter Aortic Valve Replacement (TAVR) Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location status: Recruiting

Location contact

Sebastian J Reinstadler, MD, PhD

CONTACT

[email protected]

+43 512 504 25665

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Major adverse cardiovascular events (MACE) at 12 months

    Time frame: 12 months after randomization

    MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding events. All events will be adjudicated by an independent, blinded clinical events committee.

Secondary outcomes

  1. All-cause mortality at 12 months

    Time frame: 12 months after randomization

    All-cause mortality is defined as death from any cause.

  2. Cardiovascular mortality at 12 months

    Time frame: 12 months after randomization

    Cardiovascular death is defined as any death due to proximate cardiac or vascular cause, including death during ICA, PCD-CT, or TAVR procedures.

  3. Nonfatal myocardial infarction at 12 months

    Time frame: 12 months after randomization

    Nonfatal myocardial infarction will be defined according to the Fourth Universal Definition and the VARC-3 criteria, including periprocedural and spontaneous events.

  4. Nonfatal stroke at 12 months

    Time frame: 12 months after randomization

    Nonfatal stroke is defined as a neurological deficit ≥24 hours caused by ischemia or intracranial bleeding, classified per VARC-3.

  5. Urgent revascularization at 12 months

    Time frame: 12 months after randomization

    Defined as unplanned hospital admission or in-hospital acute coronary syndrome requiring revascularization during the same hospitalization.

  6. Bleeding events at 12 months

    Time frame: 12 months after randomization

    Bleeding events will be classified according to VARC-3 bleeding definitions, types 2 to 4.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Lechner, MD, PhD

CONTACT

[email protected]

+43 512 504 25665

Sebastian J Reinstadler, MD, PhD

CONTACT

[email protected]

+43 512 504 25665

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Acronym: TAVR-CT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 6, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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