Optimized Expansion of the Implanted Transcatheter Aortic Valve
Recruiting · NCT07042529 · Interventional (participants receive a specific treatment) · Lead sponsor: Ole De Backer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
17 locations listed.
- Skejby Hospital - Aa, Denmark
- Aalborg University Hospital - Aalborg, Denmark
- AZORG ziekenhuis - Aalst, Belgium
- UMC Amsterdam - Amsterdam, Netherlands
- CHU Charleroi - Charleroi, Belgium
- Rigshospitalet - Copenhagen, Denmark
- Sahlgrenska University Hospital - Gothenburg, Sweden
- University Medical Center Groningen - Groningen, Netherlands
- Haukeland hospital - Haukeland, Norway
- Leiden University Medical Center - Leiden, Netherlands
- UZ Leuven - Leuven, Belgium
- St. Antonius Hospital - Nieuwegein, Netherlands
- Odense University Hospital - Odense C, Denmark
- Oslo universitetssygehus - Oslo, Norway
- AZ Delta - Roeselare, Belgium
- Skånes universitetssjukhus - Skåne, Sweden
- Turku University Hospital - Turku, Finland