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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Severe symptomatic aortic stenosis patients with an indication for TAVI
• Ability to understand and to comply with the study protocol
Locations
Other Locations
Belgium
CHU Charleroi
NOT_YET_RECRUITING
Charleroi
UZ Leuven
NOT_YET_RECRUITING
Leuven
Denmark
Skejby Hospital
NOT_YET_RECRUITING
Aa
Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
NOT_YET_RECRUITING
Odense C
Finland
Turku University Hospital
NOT_YET_RECRUITING
Turku
Netherlands
St. Antonius Hospital
NOT_YET_RECRUITING
Nieuwegein
Norway
Oslo universitetssygehus
NOT_YET_RECRUITING
Oslo
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Contact Information
Primary
Ole De Backer, MD, PhD, FESC
ole.de.backer@regionh.dk
+4535457086
Backup
Troels H Jørgensen, MD, PhD
troels.hoejsgaard.joergensen.01@regionh.dk
+4535450892
Time Frame
Start Date:2025-10-05
Estimated Completion Date:2033-07-01
Participants
Target number of participants:620
Treatments
Active_comparator: SoC-TAVI
Pre-dilatation and post-dialation optional, as per operator preference. The balloon size used for pre- or post-dilatation is left at the operator's discretion. Operators are only encouraged to post-dilate the implanted transcatheter aortic valve (TAV) in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient.
Experimental: OptEx-TAVI
Systematic pre-dilatation and post-dilatation with an optimally-sized balloon