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Optimized Expansion of the Implanted Transcatheter Aortic Valve

RecruitingNAAges 18 Years - anyAllOle De Backer
NCT07042529 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial. The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI. The primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Severe native aortic valve stenosis * Indication for TAVI * Ability to understand and to comply with the study protocol Exclusion Criteria: * Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve) * Creatinine clearance \<15 mL/min (CKD-EPI formula) or on renal replacement therapy * Iodine contrast allergy or other condition that prohibits cardiac CT imaging
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What it tests

  • OptEx-TAVI
  • SoC-TAVI
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Where

17 sites
AZORG ziekenhuis
Aalst, Belgium
CHU Charleroi
Charleroi, Belgium
UZ Leuven
Leuven, Belgium
AZ Delta
Roeselare, Belgium
Skejby Hospital
Aa, Denmark
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense C, Denmark

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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