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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
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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
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Secondary ID [1]
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5168-CTIA-Feb/2025-117711
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of cases achieving technical success
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Assessment method [1]
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Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or cardiac structural complication
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Timepoint [1]
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At exit from procedure room after procedure completion
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Secondary outcome [1]
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Proportion of cases achieving device success
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Assessment method [1]
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Technical success and intended performance of the valve (mean gradient less than 20 mmHg, peak velocity less than 3 m/s, Doppler velocity index greater than 0.35, and less than moderate aortic regurgitation)
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Timepoint [1]
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At 30 days after the procedure
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Secondary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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At baseline
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Secondary outcome [3]
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New conduction disturbance and permanent pacemaker implantation
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Assessment method [3]
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Timepoint [3]
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At 30 days and 1 year after the procedure
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Secondary outcome [4]
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Stroke or transient ischemic attack
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Assessment method [4]
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Timepoint [4]
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At 30 days and 1 year after the procedure
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Secondary outcome [5]
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Major vascular complication
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Assessment method [5]
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Timepoint [5]
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At 30 days after the procedure
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Secondary outcome [6]
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Moderate or severe paravalvular regurgitation
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Assessment method [6]
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Timepoint [6]
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At 30 days and 1 year after the procedure
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Secondary outcome [7]
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Death
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Assessment method [7]
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Timepoint [7]
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At 30 days and 1 year after the procedure
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Secondary outcome [8]
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Acute valve complication
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Assessment method [8]
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Timepoint [8]
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At 30 days and 1 year after the procedure
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Secondary outcome [9]
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Need for cardiac surgery
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Assessment method [9]
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Timepoint [9]
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At 30 days and 1 year after the procedure
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Secondary outcome [10]
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Delayed valve dysfunction
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Assessment method [10]
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Timepoint [10]
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At 1 year after the procedure
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Secondary outcome [11]
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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
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Assessment method [11]
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Timepoint [11]
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At baseline
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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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/05/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
290
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [2]
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North Shore Private Hospital - St Leonards
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Recruitment hospital [3]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [4]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [5]
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St Andrew's War Memorial Hospital - Spring Hill
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Recruitment hospital [6]
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The Alfred - Melbourne
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Recruitment hospital [7]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4032 - Chermside
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Recruitment postcode(s) [4]
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4000 - Spring Hill
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Canada
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State/province [3]
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Quebec
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Country [4]
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Colombia
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State/province [4]
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Bogotá
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Country [5]
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Costa Rica
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State/province [5]
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San José
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Country [6]
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Mexico
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State/province [6]
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Ciudad de México
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Country [7]
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New Zealand
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State/province [7]
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Wellington
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Country [8]
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Singapore
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State/province [8]
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Singapore
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Country [9]
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Thailand
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State/province [9]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
World Health Research Inc.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Edwards Lifesciences
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are: 1. Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room? 2. Does the ABC Bicuspid Sizing Algorithm increase the device success at 30 days after the procedure? Participants already being evaluated for a TAVR as part of their regular medical care for bicuspid aortic stenosis will have their diagnostic images assessed using the ABC Bicuspid Sizing Algorithm to help determine their procedure type and valve size. They will have visits 30 days and one year after their procedure.
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Trial website
https://clinicaltrials.gov/study/NCT06991517
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tej Sheth, MD, FRCPC
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Address
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McMaster University, World Health Research Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sarah Tawadros, MD
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Address
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Country
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Phone
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289-768-8223
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Fax
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Email
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sarah.tawadros@worldhealthresearch.ca
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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
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