NCT06559332 Coronary Artery Disease Assessment Strategies in TAVI Patients
| NCT ID | NCT06559332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Transcatheter Aortic Valve Replacement |
| Study Type | INTERVENTIONAL |
| Enrollment | 546 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 546 participants in total. It began in 2025-03-11 with a primary completion date of 2030-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Jonas Lanz, MD, MSc
PRINCIPAL INVESTIGATOR
University of Bern
Frequently Asked Questions
Who can join the NCT06559332 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Transcatheter Aortic Valve Replacement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06559332 currently recruiting?
Yes, NCT06559332 is actively recruiting participants. Contact the research team at jonas.lanz@insel.ch for enrollment information.
Where is the NCT06559332 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06559332 clinical trial?
NCT06559332 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Jonas Lanz, MD, MSc at University of Bern. The trial plans to enroll 546 participants.