NCT07042529

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: Ole De Backer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 620 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either : * SoC-TAVI (N = 310) or * OptEx-TAVI (N = 310) All patients with indication for TAVI and eligible in relation to the study in- and exclusion criteria will be offered participation in the OptEx-TAVI trial. Inclusion criteria: * Severe symptomatic aortic stenosis patients with an indication for TAVI * Ability to understand and to comply with the study protocol Exclusion criteria: * 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 Baseline characteristics, medical history, procedural details, electrocardiogram, echocardiography and cardiac CT-scan parameters will be recorded by assessing medical charts and patient interview. During the TAVI-procedure, patients will be treated according to randomisation to either SoC or OptEx Planned post-procedural visits at: * Discharge: on-site - including transthoracic echocardiography (TTE) * 3 months visit (± 2 months): on-site - including TTE and cardiac CT scan * 1 year (± 3 months): on-site - including TTE and cardiac CT scan * 5 years (± 6 months): on-site - including TTE and cardiac positron emission tomography (PET)-CT scan

Conditions

• Aortic Stenosis Disease
• Valvular Heart Disease

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2025-10-05
• Primary completion: 2032-07-01
• Completion: 2033-07-01
• First posted: 2025-06-29
• Last updated: 2026-02-03

Locations

10 sites across 6 countries: Belgium, Denmark, Finland, Netherlands, Norway, Sweden