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NCT Number: NCT06991517

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

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

North Shore Private Hospital, St Leonards, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • 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

Treatment and study plan

The ABC Bicuspid Sizing Algorithm

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of cases achieving device success

    Time frame: At 30 days after the procedure

    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)

  2. 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

  3. New conduction disturbance and permanent pacemaker implantation

    Time frame: At 30 days and 1,3 and 5 years after the procedure

  4. Stroke or transient ischemic attack

    Time frame: At 30 days and 1,3 and 5 years after the procedure

  5. Major vascular complication

    Time frame: At 30 days after the procedure

  6. Death

    Time frame: At 30 days and 1,3 and 5 years after the procedure

  7. Acute valve complication

    Time frame: Perioperative/Periprocedural

  8. Need for cardiac surgery

    Time frame: At 30 days and 1,3 and 5 years after the procedure

  9. Delayed valve dysfunction

    Time frame: At 30 days ,1,3 and 5 years after the procedure

  10. 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

  11. Hospitalization for acute heart failure

    Time frame: 1,3 and 5 years after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Naus

CONTACT

[email protected]

416-706-2579

Sarah Tawadros, MD

CONTACT

[email protected]

647-783-3521

Sponsors and collaborators

Lead sponsor

World Health Research Inc.

Industry

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
May 28, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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