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Optimized Expansion of the Implanted Transcatheter Aortic Valve

ConditionsAortic Stenosis DiseaseValvular Heart Disease
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

This trial does not accept healthy volunteers

Qualifiers

Severe native aortic valve stenosis

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

Design model

Parallel

Treatments tested in this trial

  • OptEx-TAVI

    Procedure/Surgery

    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.

  • SoC-TAVI

    Procedure/Surgery

    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.

Treatment groups

1,010 Participants
are divided into 2 treatment groups
Group A: SoC-TAVIActive comparator 1 intervention
Group B: OptEx-TAVIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ole De Backer

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov
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