Optimized Expansion of the Implanted Transcatheter Aortic Valve
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOle De Backer
About this trial
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 criteria
Qualifiers
Severe symptomatic aortic stenosis patients with an indication for TAVI
Ability to understand and to comply with the study protocol
Disqualifiers
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
Trial design
Treatments tested in this trial
- OptEx-TAVI
- SoC-TAVI
Treatment groups
620 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ole De Backer
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov