Post-Dilatation Effect on TAVI Prostheses Expansion

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.

Eligibility

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

Conditions2

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