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Post-Dilatation in Balloon-Expandable TAVI Prostheses

NCT07477002 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

  • Aortic Valve Stenosis

Interventions

OTHER

Post-dilatation

Nominal post-dilatation using the original delivery balloon

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-05-31
Completion
2031-05-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477002 on ClinicalTrials.gov