Optimized Expansion of the Implanted Transcatheter Aortic Valve
Key facts
- Where
- Aa, Aalborg, Copenhagen, and Odense C, DenmarkSee the 4 sites
Where in Denmark
- Skejby HospitalAa, DenmarkNot yet recruiting
- Aalborg University HospitalAalborg, DenmarkTaking people
- RigshospitaletCopenhagen, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ole De Backer
- Trial code
- NCT07042529
- Record updated
- 10 July 2026
- Original description
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.Read full original descriptionShow less
Optimized Expansion of the Implanted Transcatheter Aortic Valve to Reduce Hypoattenuating Leaflet Thickening in Non-atrial Fibrillation Patients Undergoing Transcatheter Aortic Valve Implantation: an International, Multicentre, Randomized Controlled Trial
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.
Inclusion: Severe native aortic valve stenosis; Indication for TAVI; Ability to understand and to comply with the study protocol.
Exclusion: Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve); Iodine contrast allergy or other condition that prohibits cardiac CT imaging; Creatinine clearance <15 mL/min (CKD-EPI formula) or on renal replacement therapy.