Post-Dilatation in Balloon-Expandable TAVI Prostheses

NCT07477002 · tracked via the Priya Life Science Austria tracker

Sponsor

Medical University of Vienna

Phase

Not applicable

Started

2025-01-01

Last updated

2026-07-10

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Post-dilatation

Post-dilatation: Nominal post-dilatation using the original delivery balloon

Study summary

Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic 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 DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Severe AS * AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board * Anatomical feasibility to receive a balloon-expandable THV * Age 65 years or older * Informed consent Exclusion Criteria: * Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated) * Bicuspid aortic valve anatomy * Valve-in-valve procedure * Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture * Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing

Primary outcome measure(s)

THV-asymmetry index — Peri-procedural
The THV-asymmetry index will be calculated from freeze-frame fluoroscopic images as: \[(longer THV height/shorter THV height) - 1\] × 100. Minimum value: 0 Maximum value: NA Higher values indicate more asymmetry.

Trial sites (1)

Facility	City	Region	Status
Medical University of Vienna	Vienna	State of Vienna

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07477002 on ClinicalTrials.gov ↗ ← All trials in Austria