Optimized expansion of implanted transcatheter aortic valves to reduce leaflet thickening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Severe native aortic valve stenosis
* 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 it's running

• AZORG ziekenhuis
  Aalst, Belgium Recruiting
• CHU Charleroi
  Charleroi, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• AZ Delta
  Roeselare, Belgium Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Ole De Backer, MD, PhD, FESC — The Heart Center, Rigshospitalet
• Study coordinator: Ole De Backer, MD, PhD, FESC
• Email: ole.de.backer@regionh.dk
• Phone: +4535457086

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.