A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 27
- 主要终点
- Proportion of cases achieving technical success
研究概览
简要总结
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:
- Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of cases achieving technical success
时间窗: At exit from procedure room after procedure completion
Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or cardiac structural complication
次要结局
- Major vascular complication(At 30 days after the procedure)
- Delayed valve dysfunction(At 30 days ,1,3 and 5 years after the procedure)
- Hospitalization for acute heart failure(1,3 and 5 years after the procedure)
- Acute valve complication(Perioperative/Periprocedural)
- Need for cardiac surgery(At 30 days and 1,3 and 5 years after the procedure)
- New conduction disturbance and permanent pacemaker implantation(At 30 days and 1,3 and 5 years after the procedure)
- Stroke or transient ischemic attack(At 30 days and 1,3 and 5 years after the procedure)
- Death(At 30 days and 1,3 and 5 years after the procedure)
- Proportion of cases achieving device success(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(At baseline)
- 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(At baseline)