RecruitingNot ApplicableNCT07477002

Post-Dilatation Effect on TAVI Prostheses Expansion

Effects of Post-Dilatation on Valve Hemodynamics, Durability and Outcome in Balloon-Expandable TAVI Prostheses (The Randomized-Controlled DUOTAP Trial).

Sponsor

Medical University of Vienna

Enrollment

146 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis

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

Min Age: 65 Years

Inclusion Criteria5

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 Criteria6

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

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