Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Fluoroscopic valve expansion
研究概览
简要总结
The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.
The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.
Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.
详细描述
The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial comparing routine versus discretionary balloon post-dilation strategies following TAVI using the SAPIEN 3 balloon-expandable THV for severe aortic stenosis (AS).
Patients with severe symptomatic aortic valve disease that are accepted for TAVI using a balloon-expandable THV. Currently, the only balloon-expandable THV in routine clinical practice in Australia are the Sapien 3 Ultra and Sapien 3 Ultra Resilia (Edwards Lifesciences, Irvine CA, USA). Patients will be recruited from three TAVI centres participating in the ACE registry: The Alfred Hospital, Cabrini Hospital and Epworth Hospital are all located in Melbourne, Australia.
Specific sub-groups may benefit more from balloon post-dilation (BPD), and hence exploratory analyses will be performed to examine the effect of BPD on primary endpoints in the following subgroups:
- Male vs Female
- Pre-dilation vs no pre-dilation
- Tricuspid vs bicuspid aortic valve
- Very severe AS (mean pressure gradient > 50mmHg)
- Very aortic valve high calcium score (>3000 in males, >1900 in females)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Imaging analysis will be performed by investigators blinded to treatment allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
- •Tricuspid or bicuspid aortic valve stenosis
排除标准
- •Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure
- •TAVI performed for native valve aortic regurgitation
- •High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.
研究组 & 干预措施
Routine deployment
Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV
Routine double tap
Participants in the double tap arm will undergo a second inflation of the delivery system balloon at the same filll volume after satisfactory initial deployment of the balloon-expandable THV
干预措施: 'Double tap' balloon post-dilation (Other)
结局指标
主要结局
Fluoroscopic valve expansion
时间窗: Day 1 post-procedure
Percentage (%) final valve expansion measured by fluoroscopy
次要结局
- Haemodynamic performance(Day 1-3 post-procedure)
- Freedom from cardiovascular death or valve reintervention(1 year and 3 years post-procedure)
研究者
Nalin Dayawansa
Associate Investigator
The Alfred