Tests a new way of expanding heart valves during TAVI procedures
Compares an optimized valve expansion method with standard care in adults with aortic stenosis.
Plain-language title generated from the registry record
Registry title: Optimized Expansion of the Implanted Transcatheter Aortic Valve
Key facts
- Where
- Haukeland and Oslo, NorwaySee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe aortic valve narrowing who are due to have a transcatheter aortic valve implantation (TAVI). It compares two ways of doing the procedure.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Severe narrowing (stenosis) of the native aortic valve, with an indication for TAVI
Main reasons for not taking part
- Already needs blood-thinning tablets (oral anticoagulation), for example because of atrial fibrillation, venous thromboembolism, antiphospholipid syndrome or a mechanical mitral valve
- Creatinine clearance below 15 mL/min, or on renal replacement therapy
- Iodine contrast allergy or another condition that rules out a cardiac CT scan
- Cannot understand or follow the study protocol
Read by machine on 12 November 2026.
Where in Norway
- Haukeland hospitalHaukeland, NorwayContact: Erik Packer, MDTaking people
- Oslo universitetssygehusOslo, NorwayContact: Kristoffer Engh Russell, MD, PhDTaking people
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.