RecruitingNot Applicable

Post-Dilatation Effect on TAVI Prostheses Expansion

Austria146 participantsStarted 2025-01-01

Plain-language summary

Asymmetrical and inadequate expansion of trans-catheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bio-prosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUO-TAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, asymmetry, hemodynamic, durability, and associated clinical outcomes in patients with severe aortic stenosis.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Severe AS * AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board * Anatomical feasibility to receive a balloon-expandable TAVI * Age 65 years or older * Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the control group and returning for all required post-procedure follow up visits, and has provided written informed consent Exclusion Criteria: * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated) * Active infections requiring current antibiotic therapy * Bicuspid aortic valve anatomy * Pregnant or planning pregnancy within next 12 months * Severe calcification of the aortic annulus protruding in the left ventricular outflow tract (predisposing for annular rupture) * Significant coronary artery disease with substantial risk of hemodynamic instability during rapid ventricular pacing

What they're measuring

TAVI asymmetry index on freeze-frame fluoroscopic images

Timeframe: Peri-procedural

Trial details

NCT IDNCT07477002

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Christian Nitsche, MD, PhD

+43-1-40400-48590 christian.nitsche@meduniwien.ac.at