Early access
Sign in
Taking people in SingaporeNo phase

Sizing method for heart valve replacement in bicuspid aortic stenosis

Tests a sizing method for valve replacement in people with bicuspid aortic stenosis.

Key facts

Who runs it
World Health Research Inc.
Where
Singapore, SingaporeSee the siteAlso in 7 other countries, 19 sites
Trial code
Registry title
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with a bicuspid aortic valve (a heart valve with two flaps instead of three) and severe narrowing, who are being checked for TAVR, a valve replacement through a tube in a blood vessel.

Sex
All sexes can join.
Disease stage
Severe aortic stenosis, or narrowing mixed with a leaky valve, that needs treatment. No other condition that needs surgery.
Earlier treatment
People must have had a TAVR CT scan of good quality, with images of the aortic root at several heart phases.

Main reasons for not taking part

  • Treated with TAVR using a valve other than Sapien 3.
  • Unable to have TAVR because of another illness, unstable health, or death while waiting.
  • TAVR is too risky because of possible blocking of the heart arteries, injury to the aorta, or severe calcium in the heart outflow area.
  • Valve ring area less than 275 mm² or more than 750 mm².
  • No usable access route for TAVR with a Sapien 3 valve.

The registry criteria, word for word

Show all 10 criteriaShow less

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 Singapore

Also in 7 other countries, 19 sites

  • National Heart Centre SingaporeSingapore, SingaporeContact: Sarah Tawadros, MDTaking people

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:

Read full original descriptionShow less

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

Print a page for my doctor

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
Plain-language title
Sizing method for heart valve replacement in bicuspid aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
21 July 2026