NCT07107568 Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
| NCT ID | NCT07107568 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Aortic Valve Stenosis and Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2025-08-14 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2025-08-14 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Sebastian J Reinstadler, MD, PhD
PRINCIPAL INVESTIGATOR
Medical University Innsbruck
Frequently Asked Questions
Who can join the NCT07107568 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis and Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07107568 currently recruiting?
Yes, NCT07107568 is actively recruiting participants. Contact the research team at sebastian.reinstadler@tirol-kliniken.at for enrollment information.
Where is the NCT07107568 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT07107568 clinical trial?
NCT07107568 is sponsored by Medical University Innsbruck. The principal investigator is Sebastian J Reinstadler, MD, PhD at Medical University Innsbruck. The trial plans to enroll 700 participants.