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

NCT06991517 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2025-11-28

No results posted yet for this study

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. 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 one year after their procedure.

Conditions

  • Aortic Stenosis

Interventions

OTHER

The ABC Bicuspid Sizing Algorithm

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.

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • World Health Research Inc.

    lead INDUSTRY

Principal Investigators

  • Tej PM Sheth, MD, FRCPC · McMaster University, World Health Research Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Australia
  • Canada
  • Colombia
  • Costa Rica
  • Mexico
  • New Zealand
  • Singapore
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991517 on ClinicalTrials.gov