Actively Recruiting
Coronary Artery Disease Assessment Strategies in TAVI Patients
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-08
546
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
C
Clinical Trials Unit Bern (CTU)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Coronary Artery Disease Assessment Strategies in TAVI Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe aortic stenosis defined by aortic valve area 1 cm2 or less and mean gradient 40 mmHg or higher or peak velocity 4.0 m/s or higher
- If mean gradient is below 40 mmHg and peak velocity below 4 m/s with stroke volume index 35 mL/m2 or less and left ventricular ejection fraction (LVEF) 50% or higher, then CT-derived aortic valve calcium score must be above 2000 Agatston units in men or above 1200 in women
- If mean gradient is below 40 mmHg and peak velocity below 4 m/s with stroke volume index 35 mL/m2 or less and LVEF below 50%, then either CT-derived aortic valve calcium score must be above 2000 Agatston units in men or above 1200 in women, or low-dose dobutamine stress echocardiography must show flow reserve and aortic valve area 1 cm2 or less
- Coronary calcium score 400 Agatston units or more or known coronary artery disease
- Selected for treatment with transfemoral TAVI
- Written informed consent
You will not qualify if you...
- Concomitant valvular heart disease or ascending aortic aneurysm requiring surgery or intervention
- Unprotected left main coronary stenosis greater than 50% or left main not evaluable based on coronary computed tomography angiography
- Left ventricular ejection fraction below 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Bern, Department of Cardiology
Bern, Switzerland, 3010
Actively Recruiting
Research Team
J
Jonas Lanz, MD MSc
CONTACT
T
Thomas Pilgrim, MD MPH
CONTACT
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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