Aortic StenosisNCT06991517
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
An observational study of Aortic Stenosis, run by World Health Research Inc. at 20 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- The ABC Bicuspid Sizing Algorithm
- How many people
- 290 participants
- Where
- 20 sitesin 8 countries
- Study dates
- 13 May 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to the TAVR program at select hospitals
Who may be able to join
- 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 join
- 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
Trial locations and contacts
20 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 8 countries
Canada7 sites, 7 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
- Recruiting
NovaScotia Health Authority- Halifax Infimary
Halifax, NovaScotia, B3H 3A7
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
- Not yet recruiting
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Australia6 sites, 6 recruiting
- Recruiting
The Prince Charles Hospital
Chermside, Queensland, 4032
- Recruiting
The Alfred
Melbourne, Victoria, 3004
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
- Recruiting
St Andrew's War Memorial Hospital
Spring Hill, Queensland, 4000
- Recruiting
North Shore Private Hospital
St Leonards, New South Wales, 2065
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2065
New Zealand2 sites, 2 recruiting
- Recruiting
Christchurch Hospital
Christchurch, 4710
- Recruiting
Wellington Regional Hospital
Newtown, Wellington Region, 6021
Colombia1 site, 1 recruiting
- Recruiting
Fundación Cardioinfantil - LaCardio
Bogotá, 111011
Costa Rica1 site, 1 recruiting
- Not yet recruiting
Hospital San Juan de Dios
San José, Provincia de San José, 10104
Mexico1 site, 1 recruiting
- Recruiting
Centro Médico Nacional Siglo XXI
Mexico City, 06720
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Thailand1 site, 1 recruiting
- Not yet recruiting
Ramathibodi Hospital
Bangkok, 10400
About this study
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
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:
- Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?
- 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.
Read the detailed description
This is a multi-centre, international, prospective cohort study. Approximately 290 patients who are clinically eligible for transcatheter aortic valve replacement (TAVR) will be enrolled. Using information collected with the ABC Bicuspid Sizing Algorithm, physicians will make a treatment allocation between TAVR and surgical aortic valve replacement (SAVR), and determine valve sizing and deployment for TAVR-treated patients. Included in the algorithm use is the utilization of gated computed tomography evaluation or artificial intelligence-based simulation models in select cases with borderline feasibility. The findings of these additional assessments will be shared with the treating physicians for consideration in the final treatment decision.
Of the 290 patients, an estimated 230 will be recommended to have TAVR. Data will be collected from TAVR-treated patients at baseline, procedure, hospital discharge, and 30 days and annually till 5 years after the procedure. Data will only be collected from SAVR-treated patients at baseline and procedure. Sites in Canada, Latin America, the Middle East, and Asia Pacific will participate.
- Conditions
- Aortic Stenosis
- Being tested
- The ABC Bicuspid Sizing Algorithm
- Keywords
- Bicuspid Aortic Stenosis, Transcatheter Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ABC Bicuspid Sizing AlgorithmOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases achieving technical success
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
Measured: At exit from procedure room after procedure completion
Secondary outcomes (11)
Proportion of cases achieving device success
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)
Measured: At 30 days after the procedure
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
Measured: At baseline
New conduction disturbance and permanent pacemaker implantation
Measured: At 30 days and 1,3 and 5 years after the procedure
Stroke or transient ischemic attack
Measured: At 30 days and 1,3 and 5 years after the procedure
Major vascular complication
Measured: At 30 days after the procedure
Death
Measured: At 30 days and 1,3 and 5 years after the procedure
Acute valve complication
Measured: Perioperative/Periprocedural
Need for cardiac surgery
Measured: At 30 days and 1,3 and 5 years after the procedure
Delayed valve dysfunction
Measured: At 30 days ,1,3 and 5 years after the procedure
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
Measured: At baseline
Hospitalization for acute heart failure
Measured: 1,3 and 5 years after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start13 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Health Research Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Tej PM Sheth, MD, FRCPC, Principal investigator, McMaster University, World Health Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991517
- Sponsor's protocol ID
- 5168-CTIA-Feb/2025-117711
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06991517
- Acronym / sponsor ID
- 5168-CTIA-Feb/2025-117711
- Conditions
- Aortic Stenosis
- Keywords
- Bicuspid Aortic Stenosis, Transcatheter Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- World Health Research Inc.Industry (pharma, biotech, devices)
- Collaborators
- Edwards Lifesciences
- Study start
- 13 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?
- 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.
Detailed description
This is a multi-centre, international, prospective cohort study. Approximately 290 patients who are clinically eligible for transcatheter aortic valve replacement (TAVR) will be enrolled. Using information collected with the ABC Bicuspid Sizing Algorithm, physicians will make a treatment allocation between TAVR and surgical aortic valve replacement (SAVR), and determine valve sizing and deployment for TAVR-treated patients. Included in the algorithm use is the utilization of gated computed tomography evaluation or artificial intelligence-based simulation models in select cases with borderline feasibility. The findings of these additional assessments will be shared with the treating physicians for consideration in the final treatment decision.
Of the 290 patients, an estimated 230 will be recommended to have TAVR. Data will be collected from TAVR-treated patients at baseline, procedure, hospital discharge, and 30 days and annually till 5 years after the procedure. Data will only be collected from SAVR-treated patients at baseline and procedure. Sites in Canada, Latin America, the Middle East, and Asia Pacific will participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to the TAVR program at select hospitals
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ABC Bicuspid Sizing AlgorithmThe 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. | Other | – |
Primary outcome
Proportion of cases achieving technical success
Time frame: At exit from procedure room after procedure completion
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
11 secondary outcomes
Proportion of cases achieving device success
Time frame: At 30 days after the procedure
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
Time frame: At baseline
New conduction disturbance and permanent pacemaker implantation
Time frame: At 30 days and 1,3 and 5 years after the procedure
Stroke or transient ischemic attack
Time frame: At 30 days and 1,3 and 5 years after the procedure
Major vascular complication
Time frame: At 30 days after the procedure
Death
Time frame: At 30 days and 1,3 and 5 years after the procedure
Acute valve complication
Time frame: Perioperative/Periprocedural
Need for cardiac surgery
Time frame: At 30 days and 1,3 and 5 years after the procedure
Delayed valve dysfunction
Time frame: At 30 days ,1,3 and 5 years after the procedure
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
Time frame: At baseline
Hospitalization for acute heart failure
Time frame: 1,3 and 5 years after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tej PM Sheth, MD, FRCPC principal investigator
McMaster University, World Health Research Inc.
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by World Health Research Inc. at 20 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada, Australia, New Zealand, Colombia, Costa Rica and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Tawadros, MD (647-783-3521, sarah.tawadros@worldhealthresearch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases achieving technical success (time frame: At exit from procedure room after procedure completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.