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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease(CAD); Transcatheter Aortic Valve Replacement (TAVR); Aortic Valve Stenosis and Insufficiency
• Intervention / Treatment: Diagnostic test: PCD-CT-Guided Diagnostic Strategy; Diagnostic test: Standard Invasive Coronary Angiography

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian J Reinstadler, MD, PhD; Phone Number: +43 512 504 25665; Email: sebastian.reinstadler@tirol-kliniken.at
• Study Contact Backup: Name: Ivan Lechner, MD, PhD; Phone Number: +43 512 504 25665; Email: ivan.lechner@tirol-kliniken.at

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medical University of Innsbruck
    • Contact: Sebastian J Reinstadler, MD, PhD; Phone Number: +43 512 504 25665; Email: sebastian.reinstadler@tirol-kliniken.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCD-CT-Guided Diagnostic Strategy; 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.	Diagnostic test: PCD-CT-Guided Diagnostic Strategy; 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.
Active Comparator: Standard Invasive Coronary Angiography; 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.	Diagnostic test: Standard Invasive Coronary Angiography; Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 events. All events will be adjudicated by an independent, blinded clinical events committee.	12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 12 months	All-cause mortality is defined as death from any cause.	12 months after randomization
Cardiovascular mortality at 12 months	Cardiovascular death is defined as any death due to proximate cardiac or vascular cause, including death during ICA, PCD-CT, or TAVR procedures.	12 months after randomization
Nonfatal myocardial infarction at 12 months	Nonfatal myocardial infarction will be defined according to the Fourth Universal Definition and the VARC-3 criteria, including periprocedural and spontaneous events.	12 months after randomization
Nonfatal stroke at 12 months	Nonfatal stroke is defined as a neurological deficit ≥24 hours caused by ischemia or intracranial bleeding, classified per VARC-3.	12 months after randomization
Urgent revascularization at 12 months	Defined as unplanned hospital admission or in-hospital acute coronary syndrome requiring revascularization during the same hospitalization.	12 months after randomization
Bleeding events at 12 months	Bleeding events will be classified according to VARC-3 bleeding definitions, types 2 to 4.	12 months after randomization

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Sebastian J Reinstadler, MD, PhD, Medical University of Innsbruck; Principal Investigator: Martin Reindl, MD, PhD, Medical University of Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Transcatheter Aortic Valve Replacement; TAVR; PCD-CT; Severe Aortic Stenosis; TAVR-CT; Photon-Counting Detector CT
• Additional Relevant MeSH Terms: Aortic Valve Disease; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Stenosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 1124/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No