620
Participants
Start Date
September 1, 2025
Primary Completion Date
July 1, 2032
Study Completion Date
July 1, 2033
OptEx-TAVI
"During TAVI with either self-expanding or balloon-expandable TAVs:~* Pre-dilatation: systematic pre-dilatation with an optimally-sized balloon.~* Post-dilatation: systematic TAV post-dilatation with an optimally-sized balloon.~Optimally-sized balloon:~1. The recommended balloon size used for pre- and post-dilatation is the perimeter-derived mean diameter of the native aortic annulus minus 1 mm and should never exceed the perimeter-derived mean diameter of the native aortic annulus. A smaller-sized balloon should be considered in case of severe left ventricular outflow tract calcium and/or severely calcified leaflets in combination with a shallow sinus of Valsalva.~2. In case of post-dilatation of the Evolut TAV (Medtronic, USA), the instructions for use (IFU) for post-dilatation of the Evolut valve should be respected.~3. Also, a balloon-expandable TAV has to be post-dilated with an optimally-sized balloon in case of randomization to the OptEx-TAVI arm."
SoC-TAVI
During TAVI with either self-expanding or balloon-expandable TAVs: Pre-dilatation: optional, as per operator preference and post-dilatation: optional, as per operator preference. Operators are only encouraged to post-dilate the implanted TAV in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient. The balloon size used for pre- or post-dilatation is left at the operator's discretion.
UZ Leuven, Leuven
St. Antonius Hospital, Nieuwegein
Odense University Hospital, Odense C
CHU Charleroi, Charleroi
Skejby Hospital, Aa
Aalborg University Hospital, Aalborg
Turku University Hospital, Turku
Rigshospitalet, Copenhagen
Oslo universitetssygehus, Oslo
Sahlgrenska University Hospital, Gothenburg
Ole De Backer
OTHER