RecruitingNot ApplicableNCT06559332

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


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

546 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Invasive coronary angiography and Risk-based CAD management for people with coronary artery disease, heart disease risk factors, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTRisk-based CAD management

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

DIAGNOSTIC_TESTInvasive coronary angiography

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.


Locations(1)

University Hospital Bern, Department of Cardiology

Bern, Switzerland

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NCT06559332


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