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Study identifier: NCT06991517 Synced from ClinicalTrials.gov · July 29, 2026
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A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm

Condition: Aortic Stenosis  ·  Sponsor: World Health Research Inc.

PhaseN/A
Planned participants290
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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 annually till 5 years after their procedure.

This description comes directly from the study's public registry record.

Talk to the study team

Sarah Tawadros, MD  ·  647-783-3521  ·  sarah.tawadros@worldhealthresearch.ca

Frank Naus  ·  416-706-2579  ·  frank.naus@worldhealthresearch.ca

Always discuss trial participation with your own doctor first.

Locations (20)

North Shore Private HospitalSt Leonards, New South Wales, AustraliaRecruiting
Royal North Shore HospitalSt Leonards, New South Wales, AustraliaRecruiting
The Prince Charles HospitalChermside, Queensland, AustraliaRecruiting
St Andrew's War Memorial HospitalSpring Hill, Queensland, AustraliaRecruiting
The AlfredMelbourne, Victoria, AustraliaRecruiting
Fiona Stanley HospitalMurdoch, Western Australia, AustraliaRecruiting
Foothills Medical CentreCalgary, Alberta, CanadaRecruiting
NovaScotia Health Authority- Halifax InfimaryHalifax, NovaScotia, CanadaRecruiting
Hamilton General HospitalHamilton, Ontario, CanadaRecruiting
Southlake Regional Health CentreNewmarket, Ontario, CanadaNot Yet Recruiting
University of Ottawa Heart InstituteOttawa, Ontario, CanadaRecruiting
St. Michael's HospitalToronto, Ontario, CanadaRecruiting

+ 8 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06991517