Assessing coronary artery disease in patients undergoing TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares a non-invasive risk management strategy to routine invasive coronary angiography for assessing coronary artery disease in patients with severe aortic stenosis who are selected for transcatheter aortic valve implantation (TAVI). The study aims to evaluate the impact of these assessment strategies on adverse clinical outcomes over three years, as well as patient-reported outcomes. By determining the most effective approach, the trial seeks to clarify the benefit-risk balance of routine invasive procedures in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Bern, Department of Cardiology
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Jonas Lanz, MD, MSc — University of Bern
• Study coordinator: Jonas Lanz, MD MSc
• Email: jonas.lanz@insel.ch
• Phone: +41 31 632 21 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.