Optimized Expansion of the Implanted Transcatheter Aortic Valve

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis Disease, Valvular Heart Disease

In brief

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.

Key facts

Study ID

NCT07042529

Run by

Ole De Backer

People needed

1010

Starts

2025-10-05

Expected to finish

2033-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe native aortic valve stenosis
• Indication for TAVI
• Ability to understand and to comply with the study protocol

You may not qualify if…

• 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

• Skånes universitetssjukhus — Skåne, Sweden (enrolling)
• CHU Charleroi — Charleroi, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• AZ Delta — Roeselare, Belgium (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
• AZORG ziekenhuis — Aalst, Belgium (enrolling)
• Aalborg University Hospital — Aalborg, Denmark (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• Turku University Hospital — Turku, Finland (enrolling)
• UMC Amsterdam — Amsterdam, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• St. Antonius Hospital — Nieuwegein, Netherlands (enrolling)
• Haukeland hospital — Haukeland, Norway (enrolling)
• Oslo universitetssygehus — Oslo, Norway (enrolling)
• Skejby Hospital — Aa, Denmark
• Odense University Hospital — Odense C, Denmark

Full record on ClinicalTrials.gov

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