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Status:

RECRUITING

Coronary Artery Disease Assessment Strategies in TAVI Patients

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Collaborating Sponsors:

Clinical Trials Unit Bern (CTU)

Schweizerische Herzstiftung

Conditions:

Transcatheter Aortic Valve Replacement

Coronary Artery Disease

Eligibility:

All Genders

70+ years

Phase:

NA

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 perc...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 11 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 31 2032

    Estimated Enrollment :

    546 Patients enrolled

    Trial Details

    Trial ID

    NCT06559332

    Start Date

    March 11 2025

    End Date

    March 31 2032

    Last Update

    March 21 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University Hospital Bern, Department of Cardiology

    Bern, Switzerland, 3010