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

Overview

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.

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 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.

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

Primary outcome measures

• Proportion of cases achieving technical success [Time frame: At exit from procedure room after procedure completion]

Secondary outcome measures (11)

• Proportion of cases achieving device success [Time frame: At 30 days after the procedure]
• 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]
• New conduction disturbance and permanent pacemaker implantation [Time frame: At 30 days and 1,3 and 5 years after the procedure]
• Stroke or transient ischemic attack [Time frame: At 30 days and 1,3 and 5 years after the procedure]
• Major vascular complication [Time frame: At 30 days after the procedure]
• Death [Time frame: At 30 days and 1,3 and 5 years after the procedure]
• Acute valve complication [Time frame: Perioperative/Periprocedural]
• Need for cardiac surgery [Time frame: At 30 days and 1,3 and 5 years after the procedure]
• Delayed valve dysfunction [Time frame: At 30 days ,1,3 and 5 years after the procedure]
• 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]
• Hospitalization for acute heart failure [Time frame: 1,3 and 5 years after the procedure]

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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 7 centers

• Foothills Medical Centre — Calgary
• NovaScotia Health Authority- Halifax Infimary — Halifax
• Hamilton General Hospital — Hamilton
• Southlake Regional Health Centre — Newmarket
• University of Ottawa Heart Institute — Ottawa
• St. Michael's Hospital — Toronto
• Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec

Australia · 6 centers

• North Shore Private Hospital — St Leonards
• Royal North Shore Hospital — St Leonards
• The Prince Charles Hospital — Chermside
• St Andrew's War Memorial Hospital — Spring Hill
• The Alfred — Melbourne
• Fiona Stanley Hospital — Murdoch

New Zealand · 2 centers

• Wellington Regional Hospital — Newtown
• Christchurch Hospital — Christchurch

Colombia · 1 center

• Fundación Cardioinfantil - LaCardio — Bogotá

Costa Rica · 1 center

• Hospital San Juan de Dios — San José

Mexico · 1 center

• Centro Médico Nacional Siglo XXI — Mexico City

Singapore · 1 center

• National Heart Centre Singapore — Singapore

Thailand · 1 center

• Ramathibodi Hospital — Bangkok

Identifiers

NCT: NCT06991517 · 5168-CTIA-Feb/2025-117711

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗