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Comparing two ways to check heart arteries before valve replacement

Tests a non-invasive risk-based approach against routine angiography in people with severe aortic stenosis.

Key facts

Who runs it
Insel Gruppe AG, University Hospital Bern
Where
Bern, SwitzerlandSee the site
Trial code
Registry title
Coronary Artery Disease Assessment Strategies in TAVI Patients
Status
Recruiting
People taking part
546 people, planned
Started
11 Mar 2025
Expected to end
31 Mar 2032
Type of study
Interventional, 2 groups
Treatments tested
  • Risk-based CAD management
  • Invasive coronary angiography
Record updated
8 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 70 or older with severe aortic stenosis and coronary artery disease. They are chosen to have a TAVI valve procedure through the leg artery (transfemoral).

Age
70 years or older
Sex
All sexes
Disease stage
Severe aortic stenosis, shown by heart ultrasound or CT measurements. Also a coronary calcium score of 400 Agatston units or more on the routine pre-TAVI CT, or known coronary artery disease.
Earlier treatment
Selected for transfemoral TAVI. No coronary angiography in the previous 12 months. No prior left main stenting.

Main reasons for not taking part

  • Other heart valve disease or aortic aneurysm that needs surgery or an intervention
  • Left main coronary stenosis over 50% that is unprotected, or left main that cannot be assessed on CT
  • Left ventricular ejection fraction below 30%
  • New wall motion abnormalities on heart ultrasound
  • Heart attack in the previous 12 months

The registry criteria, word for word

Show all 12 criteriaShow less

Who cannot take part

  • 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
  • Left ventricular ejection fraction (LVEF) < 30%
  • 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

Other criteria

  • 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

Where in Switzerland

  • University Hospital Bern, Department of CardiologyBern, SwitzerlandContact: Jonas Lanz, MD, MScTaking people

About the trial

What the trial wants to find out

Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • Risk-based management strategy without invasive coronary angiographyTreatment being tested

    Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.

    Treatment: Risk-based CAD management

  • Routine invasive coronary angiographyOther group

    Routine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (PCI) recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.

    Treatment: Invasive coronary angiography

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Plain-language title
Comparing two ways to check heart arteries before valve replacementGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 May 2026