NCT07430267

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

February 4, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 4, 2026

Last Update Submit

February 18, 2026

Conditions

Aortic StenosisTAVI(Transcatheter Aortic Valve Implantation)

Keywords

TAVITAVRDouble Tapballoon post-dilationBalloon-expandable TAVI

Outcome Measures

Primary Outcomes (1)

  • Fluoroscopic valve expansion

    Percentage (%) final valve expansion measured by fluoroscopy

    Day 1 post-procedure

Secondary Outcomes (3)

  • Haemodynamic performance

    Day 1-3 post-procedure

  • Haemodynamic performance

    Day 1-3 post-procedure

  • Freedom from cardiovascular death or valve reintervention

    1 year and 3 years post-procedure

Other Outcomes (3)

  • CT sub-study: final valve expansion measured by non-contrast computed tomography

    30-90 days post-procedure

  • New permanent pacemaker implantation

    30 days post-procedure

  • Stroke

    30 days post-procedure

Study Arms (2)

Routine deployment

NO INTERVENTION

Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV

Routine double tap

EXPERIMENTAL

Participants in the double tap arm will undergo a second inflation of the delivery system balloon at the same filll volume after satisfactory initial deployment of the balloon-expandable THV

Other: 'Double tap' balloon post-dilation

Interventions

'Double tap' balloon post-dilationOTHER

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

Routine double tap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
  • Tricuspid or bicuspid aortic valve stenosis

You may not qualify if:

  • Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure
  • TAVI performed for native valve aortic regurgitation
  • High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Epworth Hospital

Richmond, Victoria, 3121, Australia

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

Nalin H Dayawansa, MBBS

CONTACT

+61390765784na.dayawansa@alfred.org.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Imaging analysis will be performed by investigators blinded to treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Investigator

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data cannot be released without specific approval from the HREC committee.

Locations

AU(3)