Actively Recruiting
Optimized Expansion of the Implanted Transcatheter Aortic Valve
Led by Ole De Backer · Updated on 2026-02-03
620
Participants Needed
10
Research Sites
403 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Optimized Expansion of the Implanted Transcatheter Aortic Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe symptomatic aortic stenosis patients with an indication for TAVI
- Ability to understand and comply with the study protocol
You will not qualify if you...
- Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)
- Creatinine clearance less than 15 mL/min or on renal replacement therapy
- Iodine contrast allergy or other condition that prohibits cardiac CT imaging
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CHU Charleroi
Charleroi, Belgium, 6000
Not Yet Recruiting
2
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
3
Skejby Hospital
Aa, Denmark, 8200
Not Yet Recruiting
4
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
5
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
6
Odense University Hospital
Odense C, Denmark, 5000
Not Yet Recruiting
7
Turku University Hospital
Turku, Finland, 20520
Not Yet Recruiting
8
St. Antonius Hospital
Nieuwegein, Netherlands, 3435
Not Yet Recruiting
9
Oslo universitetssygehus
Oslo, Norway, 0450
Not Yet Recruiting
10
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Not Yet Recruiting
Research Team
O
Ole De Backer, MD, PhD, FESC
CONTACT
T
Troels H Jørgensen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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