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SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial

RecruitingNAAges 70 Years - anyAllErasmus Medical Center
NCT07872020 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years). As many of these patients are expected to outlive their prosthetic valves, the durability of the valve becomes an increasingly critical factor. Hypoattenuated leaflet thickening (HALT), a finding on post-TAVI computed tomography (CT), occurs in approximately 20% of patients and is associated with bioprosthetic valve dysfunction. Balloon-expandable valves seem more susceptible to HALT with an occurrence rate of 21%, compared to 16% for self-expanding valves. A recent study identified underexpansion of the transcatheter heart valve prosthesis as a key predictor of HALT at 30 days, which in turn was associated with a sixfold increase in cardiovascular mortality and a threefold increase in all-cau

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 70 years * Patients with severe aortic stenosis undergoing TAVI with a balloon-expandable valve * Written informed consent Exclusion Criteria: * Significant valve frame under-expansion and/or ≥ moderate paravalvular leakage warranting post-dilatation at the discretion of the treating physician * Shallow implantation depth with increased risk of valve embolization upon post-dilatation * Sievers type 1 bicuspid aortic valve with calcified raphe * Indication for oral anticoagulant therapy * Estimated glomerular filtration rate \<30 ml/min * Iodine contrast allergy
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What it tests

  • Double-TAP post-dilatation
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Where

5 sites
Uniklinik Düsseldorf
Düsseldorf, Germany
Amsterdam University Medical Center
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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