An interventional study of Double-TAP post-dilatation in Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening and Valve Expansion, sponsored by Erasmus Medical Center. Not yet recruiting at 5 sites in 2 countries. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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-cause mortality at 1 year. Moreover, data suggest that, in the absence of post-dilatation, more than 95% of balloon-expandable valve implants exhibit some degree of underexpansion. In contrast, routine post-dilatation enhances valve expansion and hemodynamic performance without significantly increasing adverse events. The double-TAP technique-re-inflation of the TAVI delivery balloon after initial valve deployment-achieves a 9-10% increase in valve frame expansion, potentially reducing HALT risk and improving long-term outcomes.
Objective: To determine whether routine double-TAP post-dilatation after balloon-expandable TAVI is safe and can reduce the incidence of HALT.
Study design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment.
Study population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation.
Study design: Investigator-initiated, multicenter, open-label, randomized trial with 1:1 allocation to routine post-dilatation using double-TAP versus no post-dilatation immediately after balloon expandable valve deployment.
Study population: 422 Patients undergoing balloon-expandable TAVI for native aortic valve stenosis
Investigational intervention: TAVI with a balloon-expandable valve followed by double-TAP post-dilatation.
1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.
This study's planned enrollment of 422 is above the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Procedure: Double-TAP post-dilatation
If patient is randomized to treatment arm the TAVI delivery balloon is aligned at valve level and reinflated to nominal volume for 3 seconds under rapid pacing.
Hypoattenuated Leaflet Thickening (HALT)
HALT (at least one thickened TAV leaflet involving \> 25% of the leaflet curvilinear dimension as assessed at cardiac CT)
Time frame: 30 days
Co-primary: VARC-3-defined safety
Composite of 1) freedom from all-cause mortality; 2) freedom from all new stroke; 3) freedom from VARC type 2 to 4 bleeding; 4) freedom from major vascular, access-related, or cardiac structural complications; 5) freedom from acute kidney injury stage 3 or 4; 6) freedom from moderate or severe aortic regurgitation; 7) freedom from new permanent pacemaker implantation caused by procedure related conduction abnormalities; and 8) freedom from surgery or intervention related to the device in accordance with the third Valve Academic Research Consortium (VARC-3) criteria at 30 days.
Time frame: 30 days
Plan to share: Undecided
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 174 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 24 months is below that.
Counting every sponsor, half of 277 studies reached it within 33 months; a quarter within 19 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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