Coronary Artery Disease Assessment Strategies in TAVI Patients

NCT06559332 | Recruiting DMC

• 1 other identifier: CAT Trial
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

  3 years

Secondary Outcomes (17)

• Patient reported health status

  3 months, 1, 3 and 5 years

• Patient reported health status

  3 months, 1, 3 and 5 years

• Patient reported health status

  3 months, 1, 3 and 5 years

• Rate of all cause death

  3 months, 1, 3 and 5 years

• Rate of cardiovascular death

  3 months, 1, 3 and 5 years

Study Arms (2)

Risk-based management strategy without invasive coronary angiography

EXPERIMENTAL

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

Diagnostic Test: Risk-based CAD management

Routine invasive coronary angiography

OTHER

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.

Diagnostic Test: Invasive coronary angiography

Interventions

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.

Risk-based management strategy without invasive coronary angiography

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.

Routine invasive coronary angiography

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Clinical Trials Unit Bern (CTU): collaborator
• Schweizerische Herzstiftung: collaborator

Study Sites (1)

University Hospital Bern, Department of Cardiology

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jonas Lanz, MD, MSc

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Lanz, MD MSc

CONTACT

+41 31 632 21 11; jonas.lanz@insel.ch

Thomas Pilgrim, MD MPH

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical event adjudication committee will be blinded to group allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2032
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: after study completion
• Access Criteria: Data will be made available upon reasonable request

Locations

CH (1)