A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm (NCT06991517)
A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: North Shore Private Hospital — St Leonards, New South Wales
🧪 Interventions in This Study
- The ABC Bicuspid Sizing Algorithm (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- North Shore Private Hospital — St Leonards, New South Wales
- Royal North Shore Hospital — St Leonards, New South Wales
- The Prince Charles Hospital — Chermside, Queensland
- St Andrew's War Memorial Hospital — Spring Hill, Queensland
- The Alfred — Melbourne, Victoria
- Fiona Stanley Hospital — Murdoch, Western Australia
- Foothills Medical Centre — Calgary, Alberta
- NovaScotia Health Authority- Halifax Infimary — Halifax, NovaScotia
- Hamilton General Hospital — Hamilton, Ontario
- Southlake Regional Health Centre — Newmarket, Ontario
- University of Ottawa Heart Institute — Ottawa, Ontario
- St. Michael's Hospital — Toronto, Ontario
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec, Quebec
- Fundación Cardioinfantil - LaCardio — Bogotá,
- Hospital San Juan de Dios — San José, Provincia de San José
- Centro Médico Nacional Siglo XXI — Mexico City,
- Wellington Regional Hospital — Newtown, Wellington Region
- Christchurch Hospital — Christchurch,
- National Heart Centre Singapore — Singapore,
- Ramathibodi Hospital — Bangkok,
📞 Contact the Study Coordinator
Phone: (647) 783-3521
Email: sarah.tawadros@worldhealthresearch.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Aortic Stenosis
- PERIGON Pivotal Trial — Los Angeles, California
- ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement — Birmingham, Alabama
- PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis — Birmingham, Alabama
- Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study — Tucson, Arizona
- Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study) — Edmonton, Alberta
- Systematic Ambulatory ECG Monitoring Following TAVI — Québec, Quebec
Explore by condition: All Aortic Stenosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.