Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses: A Pilot Prospective Randomized Trial. The 'LYTEN' Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Residual transvalvular gradient
研究概览
简要总结
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe prosthesis-patient mismatch (PPM) following the procedure.
详细描述
This is a prospective, multicenter, randomized open-label trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small (≤23mm; inner diameter ≤21 mm) stented surgical valve. Following the Heart Team'S decision to proceed with a TAVI-ViV procedure, patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a CoreValve Evolut R or Evolut PRO system. New iterations of these valve models may also be included.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with surgical aortic bioprosthetic dysfunction defined as severe aortic stenosis and/or regurgitation approved for a ViV procedure by the Heart Team
- •Stented surgical valves.
- •Small (≤23mm) surgical valve
排除标准
- •Stentless or sutureless surgical valves
结局指标
主要结局
Residual transvalvular gradient
时间窗: 30 days
Residual (maximal and mean) transvalvular gradient.
Rate of prothesis-patient mismatch (PPM) (valve performance)
时间窗: 30 days
Severe prothesis-patient mismatch (PPM) (defined as an index aortic valve area ≤0.65 cm2/m2) and/or moderate-severe aortic regurgitation (AR) (VARC-2 definition).
次要结局
- Changes in LV hypertrophy(30 days and 1 year)
- Transvalvular gradient.(1-year)
- Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.(30 days and 1 year)
- Clinical safety endpoints(30 days and 1 year)
- Exercise capacity(30 days and 1 year)
- Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.(1 year)
研究者
Josep Rodes-Cabau
Principal investigator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec