A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
The Prince Charles Hospital
NOT_YET_RECRUITING
Chermside
The Alfred
RECRUITING
Melbourne
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
John Hunter Hospital
NOT_YET_RECRUITING
New Lambton Heights
St Andrew's War Memorial Hospital
NOT_YET_RECRUITING
Spring Hill
North Shore Private Hospital
NOT_YET_RECRUITING
St Leonards
Royal North Shore Hospital
RECRUITING
St Leonards
Canada
Foothills Medical Centre
NOT_YET_RECRUITING
Calgary
NovaScotia Health Authority- Halifax Infimary
NOT_YET_RECRUITING
Halifax
Hamilton General Hospital
RECRUITING
Hamilton
Southlake Regional Health Centre
NOT_YET_RECRUITING
Newmarket
University of Ottawa Heart Institute
RECRUITING
Ottawa
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
RECRUITING
Québec
St. Michael's Hospital
RECRUITING
Toronto
Colombia
Fundación Cardioinfantil - LaCardio
NOT_YET_RECRUITING
Bogotá
Costa Rica
Hospital San Juan de Dios
NOT_YET_RECRUITING
San José
Mexico
Centro Médico Nacional Siglo XXI
NOT_YET_RECRUITING
Mexico City
Instituto Nacional de Cardiología - Ignacio Chávez