Optimized Expansion of the Implanted Transcatheter Aortic Valve

Official title

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

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.

Detailed description

A total of 1010 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either :

* SoC-TAVI (N = 505) or * OptEx-TAVI (N = 505)

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 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

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

Interventions

• 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-
• 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.

Primary outcome measures

• At least one TAV leaflet with HALT [Time frame: At three months after TAVI]

Secondary outcome measures (12)

• HALT 50% [Time frame: At 3 months/At 1 year]
• HALT 25% [Time frame: At 3 months/At 1 year]
• HALT 50%, multiple [Time frame: At 3 months/At 1 year]
• Bioprosthetic leaflet micro-calcification target-to-background ratio [Time frame: At 5 years]
• Valve performance [Time frame: At 3 months/At 1 year]
• structural valve deterioration [Time frame: At 5 years]
• Bioprosthetic valve dysfunction (BVD) [Time frame: At 5 years]
• Bioprosthetic valve failure (BVF) [Time frame: At 5 years]
• Technical success [Time frame: Periprocedural]
• Device success [Time frame: At 3 months]
• Early safety [Time frame: At 3 months]
• Clinical efficacy [Time frame: At 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Belgium · 4 centers

• AZORG ziekenhuis — Aalst
• CHU Charleroi — Charleroi
• UZ Leuven — Leuven
• AZ Delta — Roeselare

Denmark · 4 centers

• Skejby Hospital — Aa
• Aalborg University Hospital — Aalborg
• Rigshospitalet — Copenhagen
• Odense University Hospital — Odense C

Netherlands · 4 centers

• UMC Amsterdam — Amsterdam
• University Medical Center Groningen — Groningen
• Leiden University Medical Center — Leiden
• St. Antonius Hospital — Nieuwegein

Norway · 2 centers

• Haukeland hospital — Haukeland
• Oslo universitetssygehus — Oslo

Sweden · 2 centers

• Sahlgrenska University Hospital — Gothenburg
• Skånes universitetssjukhus — Skåne

Finland · 1 center

• Turku University Hospital — Turku

Identifiers

NCT: NCT07042529 · OptEx-TAVI Trial · H-25039123

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗