Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion (ACE-DOUBLE)

Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis; TAVI(Transcatheter Aortic Valve Implantation)
• Intervention / Treatment: Other: 'Double tap' balloon post-dilation

Detailed Description

The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial comparing routine versus discretionary balloon post-dilation strategies following TAVI using the SAPIEN 3 balloon-expandable THV for severe aortic stenosis (AS).

Patients with severe symptomatic aortic valve disease that are accepted for TAVI using a balloon-expandable THV. Currently, the only balloon-expandable THV in routine clinical practice in Australia are the Sapien 3 Ultra and Sapien 3 Ultra Resilia (Edwards Lifesciences, Irvine CA, USA). Patients will be recruited from three TAVI centres participating in the ACE registry: The Alfred Hospital, Cabrini Hospital and Epworth Hospital are all located in Melbourne, Australia.

Specific sub-groups may benefit more from balloon post-dilation (BPD), and hence exploratory analyses will be performed to examine the effect of BPD on primary endpoints in the following subgroups:

• Male vs Female
• Pre-dilation vs no pre-dilation
• Tricuspid vs bicuspid aortic valve
• Very severe AS (mean pressure gradient > 50mmHg)
• Very aortic valve high calcium score (>3000 in males, >1900 in females)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nalin H Dayawansa, MBBS; Phone Number: +61390765784; Email: na.dayawansa@alfred.org.au

Study Locations

• Australia
  • Victoria
    • Malvern, Victoria, Australia, 3144
      • Cabrini Hospital
      • Contact: Shane Nanayakkara, MBBS PHD; Phone Number: +61395081222; Email: S.Nanayakkara@alfred.org.au
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
      • Contact: Nalin H Dayawansa, MBBS; Phone Number: +61390765784; Email: na.dayawansa@alfred.org.au
    • Richmond, Victoria, Australia, 3121
      • Epworth Hospital
      • Contact: Stephanie English, RN; Phone Number: +61 3 9426 6693; Email: stephanie@tonywalton.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine deployment; Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV
Experimental: Routine double tap; 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; Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopic valve expansion	Percentage (%) final valve expansion measured by fluoroscopy	Day 1 post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic performance	Echocardiographic transvalvular mean pressure gradient (mmHg)	Day 1-3 post-procedure
Haemodynamic performance	Echocardiographic aortic valve area (cmsq)	Day 1-3 post-procedure
Freedom from cardiovascular death or valve reintervention	Freedom from occurrence of composite of cardiovascular death or valve reintervention	1 year and 3 years post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT sub-study: final valve expansion measured by non-contrast computed tomography	CT sub-study: final valve expansion (%) measured by non-contrast computed tomography	30-90 days post-procedure
New permanent pacemaker implantation	New permanent pacemaker implantation	30 days post-procedure
Stroke	Confirmed stroke	30 days post-procedure

Collaborators and Investigators

• Sponsor: The Alfred
• Collaborators: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Double Tap; balloon post-dilation; Balloon-expandable TAVI
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 058-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data cannot be released without specific approval from the HREC committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No