Can a simple CT scan replace an invasive heart test before valve replacement?
NCT ID NCT05750173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 150 older adults (75+) getting a new heart valve. It compared using a CT scan versus an invasive angiogram to check for blocked arteries beforehand. The goal was to see if the CT scan alone is safe and works just as well, potentially simplifying the process.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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150 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Mar 2026
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Investigational CTA-only phase: 100 consecutive patient who have not already been diagnosed with significant (≥50%) left main coronary artery (LM) or proximal stenosis of the left anterior descending artery (LAD) ans who have not previously undergone coronary revascularisation. CTA+ICA control phase: 50 consecutive patients who have not alreeady been diagnosed with significant (≥50%) left main coronary artery (LM) / proximal LAD stenosis and who have not previously undergone coronary revascularisation and will undergo CTA. If LM/ proximal LAD stenosis of (≥50%) can be ruled out and ICA is also performed prior to TAVI these patients will serve as control group.
- Ages
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75 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Investigational CTA-only Cohort * Consecutive adult patients ≥ 75 years * Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family * Ability to undergo CTA * Patient is scheduled to undergo a 30 Day and 3 Months follow-up CTA+ICA control Cohort * Consecutive adult patients ≥ 75 years * Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis * Ability to undergo CTA and ICA Exclusion Criteria: investigational CTA-only Cohort * Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% * Any prior coronary revascularization / prior aortic valve replacement * Life expectancy below 12 months * Lack of informed consent / data protection statement CTA+ICA control Cohort * Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline * Any prior coronary revascularization / prior aortic valve replacement * Life expectancy below 12 months * Lack of informed consent / data protection statement
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Klinik Floridsdorf
Vienna, 1210, Austria
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Medical University of Vienna
Vienna, 1090, Austria
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University Clinic St. Pölten
Sankt Pölten, 3100, Austria
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University Hospital Bochum / HDZ NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
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University Hospital of the Bergmannsheil gGmbH
Bochum, North Rhine-Westphalia, 44789, Germany
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Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie
Innsbruck, Tyrol, 6020, Austria
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