Optimized Expansion of the Implanted Transcatheter Aortic Valve to Reduce Hypoattenuating Leaflet Thickening in Non-atrial Fibrillation Patients Undergoing Transcatheter Aortic Valve Implantation: an International, Multicentre, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,010
- 试验地点
- 17
- 主要终点
- At least one TAV leaflet with HALT
研究概览
简要总结
Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial.
The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI.
The primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.
详细描述
A total of 1010 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either :
- SoC-TAVI (N = 505) or
- OptEx-TAVI (N = 505)
All patients with indication for TAVI and eligible in relation to the study in- and exclusion criteria will be offered participation in the OptEx-TAVI trial.
Inclusion criteria:
- Severe native aortic valve stenosis
- Indication for TAVI
- Ability to understand and to comply with the study protocol
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
- Double (Participant, Outcomes Assessor)
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 native aortic valve stenosis
- •Indication for TAVI
- •Ability to understand and to comply with the study protocol
排除标准
- •Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)
- •Creatinine clearance <15 mL/min (CKD-EPI formula) or on renal replacement therapy
- •Iodine contrast allergy or other condition that prohibits cardiac CT imaging
研究组 & 干预措施
SoC-TAVI
Pre-dilatation and post-dialation optional, as per operator preference. The balloon size used for pre- or post-dilatation is left at the operator's discretion. Operators are only encouraged to post-dilate the implanted transcatheter aortic valve (TAV) in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient.
干预措施: SoC-TAVI (Procedure)
OptEx-TAVI
Systematic pre-dilatation and post-dilatation with an optimally-sized balloon
干预措施: OptEx-TAVI (Procedure)
结局指标
主要结局
At least one TAV leaflet with HALT
时间窗: At three months after TAVI
At least one TAV leaflet with hypoattenuated leaflet thickening (HALT) involving more than the base (≥ 25% of the leaflet curvilinear dimension) as assessed at cardiac CT-scan .
次要结局
- Bioprosthetic valve dysfunction (BVD)(At 5 years)
- Technical success(Periprocedural)
- HALT 50%(At 3 months/At 1 year)
- HALT 25%(At 3 months/At 1 year)
- HALT 50%, multiple(At 3 months/At 1 year)
- Bioprosthetic leaflet micro-calcification target-to-background ratio(At 5 years)
- Valve performance(At 3 months/At 1 year)
- structural valve deterioration(At 5 years)
- Bioprosthetic valve failure (BVF)(At 5 years)
- Device success(At 3 months)
- Early safety(At 3 months)
- Clinical efficacy(At 1 year)
- Valve-related long-term clinical efficacy(At 5 years)
- Freedom from mortality(Periprocedural, at 3 months and at 1 year)
- Risk of cardiovascular mortality(At 1 year)
- Risk of non-cardiovascular mortality(At 1 year)
- Risk of acute kidney injury(At 3 months)
- Risk of bleeding(At 3 months, 1 year and 5 years (Only for those patients alive at 5 years and volunteering to undergo a F-NaF PET-CT-scan))
- Risk of stroke(At 3 months and 1 year)
- Risk of thomboembolism(At 5 years)
- Rate of successful access(Periprocedural)
- Freedom from surgery or intervention(Periprocedural and at 3 months)
- Risk of vascular complications(At 3 months)
- Risk of aortic prosthetic regurgitation(At 3 months)
- Risk of permanent pacemaker(At 3 months)
- Risk of procedure or valve-related hospitalization(At 1 year)
研究者
Ole De Backer
Professor of Cardiology, Principal investigator
Rigshospitalet, Denmark