Coronary Artery Disease Assessment Strategies in TAVI Patients

NCT ID: NCT06559332

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2032-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Risk-based management strategy without invasive coronary angiography

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

Group Type: EXPERIMENTAL

Risk-based CAD management

Intervention Type: DIAGNOSTIC_TEST

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

Routine invasive coronary angiography

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.

Group Type: OTHER

Invasive coronary angiography

Intervention Type: 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.

Interventions

Risk-based CAD management

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trials Unit Bern (CTU)

UNKNOWN

Sponsor Role: collaborator

Schweizerische Herzstiftung

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonas Lanz, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

University Hospital Bern, Department of Cardiology

Bern, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Jonas Lanz, MD MSc

Role: CONTACT

jonas.lanz@insel.ch

+41 31 632 21 11

Thomas Pilgrim, MD MPH

Role: CONTACT

Facility Contacts

Jonas Lanz, MD, MSc

Role: primary

Other Identifiers

CAT Trial

Identifier Type: -

Identifier Source: org_study_id