Actively Recruiting
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Led by Medical University Innsbruck · Updated on 2025-08-22
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether a non-invasive coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT) is as safe and effective as the current standard invasive coronary angiography (ICA) before transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis. The study tests if the PCD-CT approach is not worse than ICA in terms of major adverse cardiovascular events (MACE) occurring within 12 months. Participants are randomly assigned to one of two groups. One group will have their CAD assessed by PCD-CT, and ICA will only be done if significant CAD is detected by PCD-CT. The other group will receive routine ICA as part of standard care before TAVR. The trial is conducted across multiple centers with a randomized, single-blind design. During the study, participants will be monitored for up to 12 months after randomization to measure major adverse cardiovascular events, including death, heart attacks, strokes, urgent heart procedures, or bleeding. Researchers will collect data on these outcomes and other cardiovascular events to compare the two assessment strategies. Participants will be followed closely to ensure safety and to gather comprehensive information about the effectiveness of the diagnostic methods.
CONDITIONS
Brief Title
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe aortic valve stenosis with indication for intervention according to current European Society of Cardiology guidelines
- Candidate for transcatheter aortic valve replacement (TAVR)
- Written informed consent provided
You will not qualify if you...
- Cardiogenic shock at presentation, such as emergency indication for TAVR
- Severe kidney impairment with estimated glomerular filtration rate less than 30 mL/min/1.73 m²
- Life expectancy less than 1 year due to severe non-cardiac disease, for example, malignancy
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo diagnostic tests to assess coronary artery disease before transcatheter aortic valve replacement (TAVR). Depending on randomization, participants receive either a non-invasive photon-counting detector computed tomography (PCD-CT) or a standard invasive coronary angiography (ICA). In the PCD-CT group, invasive coronary angiography is only performed if significant disease is detected by PCD-CT.
1 to 2 visits depending on diagnostic procedures
Duration - 12 months
Participants are monitored for major adverse cardiovascular events, including all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding for 12 months after randomization.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Medical University of Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
Research Team
S
Sebastian J Reinstadler, MD, PhD
I
Ivan Lechner, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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