RecruitingNot ApplicableNCT07042529

Optimized Expansion of the Implanted Transcatheter Aortic Valve

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

Sponsor

Ole De Backer

Enrollment

620 participants

Start Date

Oct 5, 2025

Study Type

INTERVENTIONAL

Conditions

Valvular Heart Disease Aortic Stenosis Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an optimized approach to expanding a transcatheter aortic valve (TAVI) — a replacement heart valve inserted through a catheter rather than open surgery — after implantation, to improve its function. The study uses a specialized balloon to ensure the valve is fully expanded and seated correctly, potentially improving blood flow and reducing complications. **You may be eligible if...** - You have severe aortic stenosis (a narrowed aortic heart valve) that is causing symptoms - Your cardiologist has recommended a TAVI procedure - You understand and can follow the study protocol **You may NOT be eligible if...** - You already take blood thinners (anticoagulants) for conditions like atrial fibrillation, blood clots, or a mechanical heart valve - Your kidneys work very poorly (creatinine clearance below 15 mL/min) or you are on dialysis - You have an iodine or contrast dye allergy, or another condition preventing cardiac CT imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOptEx-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.

PROCEDURESoC-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.