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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06991517




Registration number
NCT06991517
Ethics application status
Date submitted
16/04/2025
Date registered
28/05/2025
Date last updated
28/05/2025

Titles & IDs
Public title
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
Scientific title
A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
Secondary ID [1] 0 0
5168-CTIA-Feb/2025-117711
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - The ABC Bicuspid Sizing Algorithm

Other interventions: The ABC Bicuspid Sizing Algorithm
The ABC Bicuspid Sizing Algorithm is a valve sizing algorithm. It guides operators' evaluations of CT scans, helping inform (1) treatment allocation between TAVR and surgical aortic valve replacement, and (2) valve choice for patients undergoing TAVR. In select cases, the algorithm will suggest gated CT evaluation or artificial intelligence-based simulation models be used to further evaluate the risk of the planned valve size and deployment volume. The operators will consider the findings of the ABC Bicuspid Sizing Algorithm as well as other clinical factors when making their final treatment decisions.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of cases achieving technical success
Timepoint [1] 0 0
At exit from procedure room after procedure completion
Secondary outcome [1] 0 0
Proportion of cases achieving device success
Timepoint [1] 0 0
At 30 days after the procedure
Secondary outcome [2] 0 0
Proportion of cases in which the use of gated computed tomography evaluation or artificial intelligence-based simulation models altered the treatment plan or operator confidence in the treatment plan compared to the ABC Bicuspid Sizing Algorithm alone
Timepoint [2] 0 0
At baseline
Secondary outcome [3] 0 0
New conduction disturbance and permanent pacemaker implantation
Timepoint [3] 0 0
At 30 days and 1 year after the procedure
Secondary outcome [4] 0 0
Stroke or transient ischemic attack
Timepoint [4] 0 0
At 30 days and 1 year after the procedure
Secondary outcome [5] 0 0
Major vascular complication
Timepoint [5] 0 0
At 30 days after the procedure
Secondary outcome [6] 0 0
Moderate or severe paravalvular regurgitation
Timepoint [6] 0 0
At 30 days and 1 year after the procedure
Secondary outcome [7] 0 0
Death
Timepoint [7] 0 0
At 30 days and 1 year after the procedure
Secondary outcome [8] 0 0
Acute valve complication
Timepoint [8] 0 0
At 30 days and 1 year after the procedure
Secondary outcome [9] 0 0
Need for cardiac surgery
Timepoint [9] 0 0
At 30 days and 1 year after the procedure
Secondary outcome [10] 0 0
Delayed valve dysfunction
Timepoint [10] 0 0
At 1 year after the procedure
Secondary outcome [11] 0 0
Proportion of cases in which evaluation of anatomy above or below the annulus altered the valve sizing and deployment decision compared to the calculated valve sizing and deployment decision considering the annulus size only
Timepoint [11] 0 0
At baseline

Eligibility
Key inclusion criteria
* Have bicuspid aortic valve disease
* Have severe aortic stenosis or mixed aortic stenosis and regurgitation requiring treatment
* Have no other condition requiring surgical intervention
* Have had a TAVR CT scan (retrospectively gated contrast enhanced acquisition) that is of diagnostic quality and includes multiphase reconstructions of the aortic root at the minimum available slice thickness (with at least three systolic and one diastolic phases)
* Would be treated with a Sapien 3 valve if found to be anatomically suitable for TAVR
* Have a suitable access route for TAVR with a Sapien 3 valve
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are treated with TAVR using a device other than a Sapien 3 valve
* Are unable to be treated with TAVR due to intercurrent illness, clinical instability, or death on waitlist after being accepted for TAVR

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
290
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
St Andrew's War Memorial Hospital - Spring Hill
Recruitment hospital [6] 0 0
The Alfred - Melbourne
Recruitment hospital [7] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4000 - Spring Hill
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Colombia
State/province [4] 0 0
Bogotá
Country [5] 0 0
Costa Rica
State/province [5] 0 0
San José
Country [6] 0 0
Mexico
State/province [6] 0 0
Ciudad de México
Country [7] 0 0
New Zealand
State/province [7] 0 0
Wellington
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Thailand
State/province [9] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
World Health Research Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Edwards Lifesciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tej Sheth, MD, FRCPC
Address 0 0
McMaster University, World Health Research Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Tawadros, MD
Address 0 0
Country 0 0
Phone 0 0
289-768-8223
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06991517