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A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm

Key facts

Who runs it
World Health Research Inc.
Where
Bangkok, ThailandSee the siteAlso in 7 other countries, 19 sites
Trial code
Status
Recruiting
People taking part
290 people, planned
Started
13 May 2025
Expected to end
Dec 2031
Type of study
Observational
Treatments tested
  • The ABC Bicuspid Sizing Algorithm
Record updated
21 July 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • 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
  • TAVR considered high risk and not feasible due to risk of coronary occlusion, risk of sino tubular junction (STJ) injury and severe LVOT calcification
  • Annular area less than 275 mm² or more than 750 mm²

Where in Thailand

Also in 7 other countries, 19 sites

  • Ramathibodi HospitalBangkok, ThailandContact: Sarah Tawadros, MDNot yet recruiting

About the trial

What the trial wants to find out

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:

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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.

Treatments tested

  • The ABC Bicuspid Sizing Algorithm

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
Record updated
21 July 2026