Overview
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.
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
Eligibility
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