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Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

NCT07430267 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-24

No results posted yet for this study

Summary

The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.

The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.

Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.

Conditions

  • Aortic Stenosis
  • TAVI(Transcatheter Aortic Valve Implantation)

Interventions

OTHER

'Double tap' balloon post-dilation

Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • The Alfred

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-04-01
Completion
2029-04-01

Countries

  • Australia

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 NCT07430267 on ClinicalTrials.gov