Aortic Valve Stenosis and InsufficiencyTAVR-CTNCT07107568
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
A study testing Standard Invasive Coronary Angiography and PCD-CT-Guided Diagnostic Strategy in people with Aortic Valve Stenosis and Insufficiency and Coronary Artery Disease(CAD), run by Medical University Innsbruck at 2 sites in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
- What is being tested?
- Standard Invasive Coronary Angiography and PCD-CT-Guided Diagnostic Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesAustria
- Study dates
- 14 Aug 2025to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, 6020
Sebastian J Reinstadler, MD, PhD, +43 512 504 25665, sebastian.reinstadler@tirol-kliniken.at
- Recruiting
Department of Internal Medicine II, Cardiology and Intensive Care Medicine, Klinikum Wels-Grieskirchen
Wels, 4600
Ronald K Binder, MD, +43 7242 415 - 2215, interne2@klinikum-wegr.at
Peter Huber, MD
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
- Being tested
- Standard Invasive Coronary Angiography, PCD-CT-Guided Diagnostic Strategy
- Keywords
- TAVR-CT, PCD-CT, Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVR, Photon-Counting Detector CT, Randomized Controlled Trial
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Invasive Coronary AngiographyDiagnostic test
Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
PCD-CT-Guided Diagnostic StrategyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| PCD-CT-Guided Diagnostic Strategy | Experimental | 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. Receives: Diagnostic Test: PCD-CT-Guided Diagnostic Strategy |
| Standard Invasive Coronary Angiography | Active comparator | 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. Receives: Diagnostic Test: Standard Invasive Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after randomization
Secondary outcomes (6)
All-cause mortality at 12 months
All-cause mortality is defined as death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after randomization
Bleeding events at 12 months
Bleeding events will be classified according to VARC-3 bleeding definitions, types 2 to 4.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start14 Aug 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve Stenosis and InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, multicenter, open-label, parallel-group, two-arm non-inferiority trial. Participants are assigned in a 1:1 ratio to either a PCD-CT-guided diagnostic strategy or standard invasive coronary angiography prior to TAVR evaluation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian J Reinstadler, MD, PhD, Principal investigator, Medical University InnsbruckMartin Reindl, MD, PhD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107568
- Sponsor's protocol ID
- 1124/2025
- Acronym
- TAVR-CT
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided