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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,010
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-sized balloon should be considered in case of severe left ventricular outflow tract calcium and/or severely calcified leaflets in combination with a shallow sinus of Valsalva. 2. In case of post-dilatation of the Evolut TAV (Medtronic, USA), the instructions for use (IFU) for post-dilatation of the Evolut valve should be respected. 3. Also, a balloon-expandable TAV has to be post-dilated with an optimally-sized balloon in case of randomization to the OptEx-TAVI arm.
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.
AZORG ziekenhuis
Aalst, Belgium
RECRUITINGCHU Charleroi
Charleroi, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGAZ Delta
Roeselare, Belgium
RECRUITINGSkejby Hospital
Aa, Denmark
NOT_YET_RECRUITINGAalborg University Hospital
Aalborg, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGOdense University Hospital
Odense C, Denmark
NOT_YET_RECRUITINGTurku University Hospital
Turku, Finland
RECRUITINGUMC Amsterdam
Amsterdam, Netherlands
RECRUITING...and 7 more locations
At least one TAV leaflet with HALT
At least one TAV leaflet with hypoattenuated leaflet thickening (HALT) involving more than the base (≥ 25% of the leaflet curvilinear dimension) as assessed at cardiac CT-scan .
Time frame: At three months after TAVI
HALT 50%
At least one TAV leaflet with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan
Time frame: At 3 months/At 1 year
HALT 25%
The rate of TAV leaflets with HALT involving ≥ 25% of the leaflet curvilinear dimension assessed by cardiac CT-scan
Time frame: At 3 months/At 1 year
HALT 50%, multiple
The rate of TAV leaflets with HALT involving ≥ 50% of the leaflet curvilinear dimension assessed by cardiac CT-scan
Time frame: At 3 months/At 1 year
Bioprosthetic leaflet micro-calcification target-to-background ratio
Ratio of bioprosthetic micro-calcification activity assessed by PET CT- scan by 18F-NaF uptake originating from the valve leaflets observed on 3 orthogonal planes after co-registration of background PET activity with contrast CT angiography. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Time frame: At 5 years
Valve performance
Intended performance of the valve (mean gradient \< 20 mmHg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation) by TTE as per VARC- 3 criteria
Time frame: At 3 months/At 1 year
structural valve deterioration
Moderate or greater hemodynamic structural valve deterioration by TTE as per VARC-3 criteria. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Time frame: At 5 years
Bioprosthetic valve dysfunction (BVD)
Severe bioprosthetic valve dysfunction (BVD) by TTE as per VARC-3 criteria. Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Time frame: At 5 years
Bioprosthetic valve failure (BVF)
As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Time frame: At 5 years
Technical success
As per VARC-3 criteria
Time frame: Periprocedural
Device success
as per VARC-3 criteria
Time frame: At 3 months
Early safety
As per VARC-3 criteria
Time frame: At 3 months
Clinical efficacy
As per VARC-3 criteria
Time frame: At 1 year
Valve-related long-term clinical efficacy
As per VARC-3 criteria; Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan
Time frame: At 5 years
Freedom from mortality
Freedom from mortality
Time frame: Periprocedural, at 3 months and at 1 year
Risk of cardiovascular mortality
Risk of cardiovascular mortality. VARC-3 criteria
Time frame: At 1 year
Risk of non-cardiovascular mortality
Risk of non-cardiovascular mortality. VARC-3 criteria
Time frame: At 1 year
Risk of acute kidney injury
Risk of acute kidney injury stage 3 or 4. VARC-3 criteria
Time frame: At 3 months
Risk of bleeding
Risk of VARC-3 type 2-4 bleeding
Time frame: At 3 months, 1 year and 5 years (Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan)
Risk of stroke
Risk of all stroke
Time frame: At 3 months and 1 year
Risk of thomboembolism
Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies). VARC-3 criteria.
Time frame: At 5 years
Rate of successful access
Successful access, delivery of the device, and retrieval of the delivery system
Time frame: Periprocedural
Freedom from surgery or intervention
Rate of freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Time frame: Periprocedural and at 3 months
Risk of vascular complications
Risk of major vascular, access-related, or cardiac structural complication, VARC-3 criteria.
Time frame: At 3 months
Risk of aortic prosthetic regurgitation
Freedom from moderate or severe aortic regurgitation. VARC-3 criteria
Time frame: At 3 months
Risk of permanent pacemaker
Risk of new permanent pacemaker due to procedure-related conduction abnormalities
Time frame: At 3 months
Risk of procedure or valve-related hospitalization
Risk of hospitalization for procedure- or valve-related causes. VARC-3
Time frame: At 1 year
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