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NCT Number: NCT06559332

Coronary Artery Disease Assessment Strategies in TAVI Patients

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).

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern, Department of Cardiology

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Jonas Lanz, MD, MSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
  • Unprotected left main coronary stenosis >50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
  • Left ventricular ejection fraction (LVEF) < 30%
  • New regional wall motion abnormalities on echocardiography
  • Myocardial infarction in previous 12 months
  • Coronary angiography in previous 12 months
  • Prior left main stenting

Treatment and study plan

Risk-based CAD management

Diagnostic Test

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

Invasive coronary angiography

Diagnostic Test

Routine invasive coronary angiography prior to TAVI. 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.

Primary outcomes

  1. Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization

    Time frame: 3 years

    Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)

Secondary outcomes

  1. Patient reported health status

    Time frame: 3 months, 1, 3 and 5 years

    Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)

  2. Patient reported health status

    Time frame: 3 months, 1, 3 and 5 years

    Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health)

  3. Patient reported health status

    Time frame: 3 months, 1, 3 and 5 years

    EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)

  4. Rate of all cause death

    Time frame: 3 months, 1, 3 and 5 years

  5. Rate of cardiovascular death

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  6. Rate of disabling strokes

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  7. Rate of myocardial infarction

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  8. Rate of unplanned, urgent revascularization

    Time frame: 3 months, 1, 3 and 5 years

  9. Rate of elective revascularization

    Time frame: 3 months, 1, 3 and 5 years

  10. Rate of cardiovascular hospitalization

    Time frame: 3 months, 1, 3 and 5 years

  11. Rate of heart failure hospitalization

    Time frame: 3 months, 1, 3 and 5 years

  12. Rate of bleeding

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  13. Rate of acute kidney injury

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  14. Rate of tachyarrhythmia

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  15. Rate of major vascular complications

    Time frame: 3months, 1, 3 and 5 years

    (VARC-3)

  16. Rate of major cardiac structural complications

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

  17. Rate of permanent pacemaker implantation

    Time frame: 3 months, 1, 3 and 5 years

    (VARC-3)

Study contacts

Contact information is provided by the study sponsor or research team.

Jonas Lanz, MD MSc

CONTACT

[email protected]

+41 31 632 21 11

Thomas Pilgrim, MD MPH

CONTACT

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Clinical Trials Unit Bern (CTU)
  • Schweizerische Herzstiftung

Registry information

Official study title

Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Acronym: CAT

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Aug 19, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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