NCT06559332Recruiting
Coronary Artery Disease Assessment Strategies in TAVI Patients
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status. As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear. The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 546 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- Mar 2025
- Primary completion date
- Mar 2030
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Coronary artery disease
- NCT number
- NCT06559332
What you commit to
- Study type: Interventional
- Planned participants: 546
- From Mar 2025 to the primary completion date, Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting
Lab values
- Left ventricular ejection fraction (LVEF) \< 30%
Other
- Unprotected left main coronary stenosis \>50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
- New regional wall motion abnormalities on echocardiography
Criteria the registry did not label
- Inclusion:
- Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s
- OR
- if mean gradient \<40 mmHg and peak velocity (Vmax) \<4 m/s and stroke volume indexed to body surface area (SVi) ≤ 35 mL/m2 and LVEF ≥50% then if CT-derived aortic valve calcium score \>2000 Agatston units in men, \>1200 in women
- OR
- if mean gradient \<40 mmHg and Vmax \<4 m/s and SVi ≤ 35 mL/m2 and LVEF \<50% then if CT-derived aortic valve calcification \>2000 Agatston units in men, \>1200 in women OR if low-dose dobutamine stress echocardiography with flow reserve (\>20% increase in stroke volume) and AVA ≤1cm2
- Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Bern, Department of Cardiology Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.