SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI
Official title: SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Run by Erasmus Medical Center · NCT07872020 · Data updated 2026-11-12
This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 422 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 5 sites (Düsseldorf and 4 other locations) |
| Status | Recruiting |
| Started | October 26, 2026 |
| Main results expected | November 1, 2028 |
| Study ends | November 1, 2033 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07872020 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 70 years or older with severe aortic stenosis undergoing balloon-expandable TAVI and without contraindications to post-dilatation or contrast.
✕Probably not a fit
Patients with significant under-expansion or moderate-to-severe paravalvular leakage requiring post-dilatation, or those needing oral anticoagulation, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial focuses on improving durability of balloon-expandable transcatheter heart valves by addressing underexpansion, which is linked to hypoattenuated leaflet thickening (HALT). Participants are patients aged 70+ with severe aortic stenosis undergoing balloon-expandable TAVI. The study uses a post-dilatation approach called Double-TAP to optimize valve expansion and potentially reduce HALT-related complications. Outcomes will center on rates of HALT, valve function, and associated clinical events. Enrollment involves multiple European centers with collaboration between Erasmus Medical Center and industry partners.
Why it matters
Potential benefit: If successful, patients may experience improved valve durability and fewer HALT-related complications.
How similar studies have gone: Previous data link valve underexpansion to HALT and worse outcomes, and post-dilatation strategies have shown promise in reducing HALT risk in some settings, making this approach exploratory but based on prior signals.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands Recruiting -
Uniklinik Düsseldorf
Düsseldorf, Germany Not yet recruiting -
Amsterdam University Medical Center
Amsterdam, Netherlands Not yet recruiting -
Amphia Hospital
Breda, Netherlands Not yet recruiting -
Maastricht University Medical Center
Maastricht, Netherlands Not yet recruiting
Study contacts
- Study coordinator: Rutger-Jan M Nuis, MD PhD
- Email: r.nuis@erasmusmc.nl
- Phone: 0031(0)107035260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.