Clinical trial NCT06991517: A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Keywords: Bicuspid Aortic Stenosis
Transcatheter Aortic Valve Replacement
Lead sponsor: World Health Research Inc.
Sponsor class: INDUSTRY
Collaborators: name: Edwards Lifesciences
First posted: 2025-05-28
Enrollment: 290
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the TAVR program at select hospitals

Brief 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.

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 one year 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of cases achieving technical success
timeFrame: At exit from procedure room after procedure completion
Secondary outcomes:
measure: Proportion of cases achieving device success
timeFrame: At 30 days after the procedure
measure: 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
timeFrame: At baseline
measure: New conduction disturbance and permanent pacemaker implantation
timeFrame: At 30 days and 1 year after the procedure
measure: Stroke or transient ischemic attack
timeFrame: At 30 days and 1 year after the procedure
measure: Major vascular complication
timeFrame: At 30 days after the procedure
measure: Moderate or severe paravalvular regurgitation
timeFrame: At 30 days and 1 year after the procedure
measure: Death
timeFrame: At 30 days and 1 year after the procedure
measure: Acute valve complication
timeFrame: At 30 days and 1 year after the procedure
measure: Need for cardiac surgery
timeFrame: At 30 days and 1 year after the procedure
measure: Delayed valve dysfunction
timeFrame: At 1 year after the procedure
measure: 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
timeFrame: At baseline
Other outcomes:
Locations:
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Spring Hill
country: Australia
facility: St Andrew's War Memorial Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
state: Quebec
city: Bogotá
country: Colombia
facility: Fundación Cardioinfantil - LaCardio
city: San José
country: Costa Rica
facility: Hospital San Juan de Dios
city: Ciudad de México
country: Mexico
facility: Centro Médico Nacional Siglo XXI
city: Ciudad de México
country: Mexico
facility: Instituto Nacional de Cardiología - Ignacio Chávez
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital
state: Wellington
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: McMaster University, World Health Research Inc.
name: Tej Sheth, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: