Optimized expansion of implanted transcatheter aortic valves to reduce leaflet thickening

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

This trial will test whether using systematic extra balloon dilatation before and after TAVI reduces leaflet thickening on CT in people with severe symptomatic aortic stenosis who are not on long‑term blood thinners.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 620 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Locations: 10 sites (Charleroi and 9 other locations)
• Trial ID: NCT07042529 on ClinicalTrials.gov

What this trial studies

This randomized, international multicentre trial will enroll 620 patients with severe symptomatic aortic stenosis and randomize them 1:1 to standard TAVI care or an optimized expansion (OptEx) strategy with systematic pre‑ and post‑dilatation. The primary outcome is the presence of at least one thickened transcatheter aortic valve leaflet (≥25% of the curvilinear leaflet dimension) on cardiac CT at three months. Baseline clinical data, ECG, echocardiography and cardiac CT parameters will be collected, and follow‑up imaging visits are planned at discharge, 3 months, 1 year and 5 years. Patients with an existing indication for oral anticoagulation, severe renal failure, or contraindication to iodine contrast are excluded.

Who should consider this trial

Good fit: Ideal candidates are people with severe symptomatic aortic stenosis scheduled for TAVI who can undergo contrast cardiac CT and do not have an indication for chronic oral anticoagulation.

Not a fit: Patients who require long‑term oral anticoagulation (for example atrial fibrillation), have severe renal impairment, or cannot receive iodinated contrast are unlikely to benefit from or be eligible for this approach.

Why it matters

Potential benefit: If successful, the optimized expansion approach could reduce early leaflet thickening and improve valve function and durability after TAVI.

How similar studies have performed: Observational and imaging studies have linked better valve expansion with less subclinical leaflet thrombosis, but randomized evidence on systematic pre‑ and post‑dilatation is limited.

Eligibility criteria

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

Where this trial is running

Charleroi and 9 other locations

• CHU Charleroi — Charleroi, Belgium (Not_yet_recruiting)
• UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
• Skejby Hospital — Aa, Denmark (Not_yet_recruiting)
• Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Odense University Hospital — Odense C, Denmark (Not_yet_recruiting)
• Turku University Hospital — Turku, Finland (Not_yet_recruiting)
• St. Antonius Hospital — Nieuwegein, Netherlands (Not_yet_recruiting)
• Oslo universitetssygehus — Oslo, Norway (Not_yet_recruiting)
• Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)

Study contacts

• Principal investigator: Ole De Backer, MD, PhD, FESC — The Heart Center, Rigshospitalet
• Study coordinator: Ole De Backer, MD, PhD, FESC

Conditions Aortic Stenosis Disease; Valvular Heart Disease; Aortic stenosis; Cardiovascular; Transcatheter aortic valve; Transcatheter aortic valve implantation; Valvular heart disease; TAVI