SUBLIME: Size Up Bicuspid with the LIra MEthod: the SUBLIME Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Device success
研究概览
简要总结
Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. There is still lack of consensus on the optimal sizing method for prosthesis selection in BAV patients.
The objective of the present study is to evaluate the efficacy and safety of the LIRA sizing method in raphe-type BAV patients undergoing TAVR.
详细描述
Bicuspid aortic valve (BAV) still represents a challenge for percutaneous treatment due to the peculiar anatomy.
BAV patients have been historically excluded from major randomized controlled trials.
Observational data have showed a high rate of paravalvular leak (PVL) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves.
More recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high.
These suboptimal results, possibly related to BAV different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •All patients over 18 years old with severe aortic stenosis and type 1 or 2 BAV according to Sievers classification) undergone TAVR with self-expanding supra-annular prostheses sized according to the LIRA method between September 2018 and June 2024
排除标准
- •Redo-TAVR
- •TAVR performed in emergency setting
- •TAVR performed for severe aortic regurgitation
结局指标
主要结局
Device success
时间窗: Up to 30 days after TAVI procedure
Device success as defined by VARC 3 criteria : presence of technical success, freedom from mortality, freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complications, intended performance of the valve (less than moderate aortic regurgitation, mean gradient \< 20 mmHg, peak velocity \<3 m/s, doppler velocity index \>0.25).
次要结局
- Number of partecipants with TAVI-related Adverse Events as assessed by VARC 3 criteria.(Up to 30 days after TAVI procedure)
- Clinical efficacy(Up to 1 year after TAVI procedure)
- Technical success(At exit from procedure room)
- Intended performance of the valve(Up to 30 days after TAVI procedure)
研究者
Matteo Montorfano
Professor, cardiologist
IRCCS San Raffaele