Coronary Artery Disease Assessment Strategies in TAVI Patients
NCT06559332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 546
Last updated 2026-05-08
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).
Conditions
- Transcatheter Aortic Valve Replacement
- Coronary Artery Disease
- Heart Disease Risk Factors
Interventions
- DIAGNOSTIC_TEST
-
Risk-based CAD management
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.
- DIAGNOSTIC_TEST
-
Invasive 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.
Sponsors & Collaborators
-
Clinical Trials Unit Bern (CTU)
collaborator UNKNOWN -
Schweizerische Herzstiftung
collaborator OTHER -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Jonas Lanz, MD, MSc · University of Bern
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-11
- Primary Completion
- 2030-03-31
- Completion
- 2032-03-31
Countries
- Switzerland
Study Locations
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