球囊扩张 Edwards 瓣和自扩张 CoreValve Evolut R 或 Evolut PRO 系统治疗小型、严重功能障碍的外科主动脉生物假体的比较。 “LYTEN”试验
球囊扩张 Edwards 瓣和自扩张 CoreValve Evolut R 或 Evolut PRO 系统治疗小型、严重功能失调的外科主动脉生物假体的比较：一项前瞻性随机试验试验。 “LYTEN”试验
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.
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Quebec
-
Québec、Quebec、加拿大、G1V 4G5
- IUCPQ
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Stentless or sutureless surgical valves
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：SAPIEN
Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve. |
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is >18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm. |
|
其他：COREVALVE
Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received the CoreValve Evolut R or Evolut PRO valve system. |
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of prothesis-patient mismatch (PPM) (valve performance)
大体时间：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). |
30 days
|
|
Residual transvalvular gradient
大体时间：30 days
|
Residual transvalvular gradient will be assessed by transthoracic echocardiography (TTE) using Doppler echocardiographic measurements. The mean and maximal transvalvular pressure gradients (mmHg) will be recorded. |
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Transvalvular gradient.
大体时间：1-year and yearly thereafter up to 10-year follow-up
|
Maximal and mean transvalvular gradient |
1-year and yearly thereafter up to 10-year follow-up
|
|
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
大体时间：30 days, 1 year and yearly thereafter up to 10-year follow-up
|
Moderate or severe PPM; moderate-severe AR. |
30 days, 1 year and yearly thereafter up to 10-year follow-up
|
|
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
大体时间：1 year and yearly thereafter up to 10-year follow-up
|
Moderate-severe AR or severe PPM. |
1 year and yearly thereafter up to 10-year follow-up
|
|
Clinical safety endpoints
大体时间：30 days, 1 year and yearly thereafter up to 10-year follow-up
|
individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction. |
30 days, 1 year and yearly thereafter up to 10-year follow-up
|
|
Exercise capacity
大体时间：30 days, 1 year and yearly thereafter up to 10-year follow-up
|
Exercise capacity as evaluated by the six-minute walk test |
30 days, 1 year and yearly thereafter up to 10-year follow-up
|
|
Changes in LV hypertrophy
大体时间：30 days , 1 year and yearly thereafter up to 10-year follow-up
|
Changes in LV hypertrophy |
30 days , 1 year and yearly thereafter up to 10-year follow-up
|
合作者和调查者
调查人员
- 首席研究员：Josep Rodés-Cabau, MD、Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
出版物和有用的链接
一般刊物
- Nuche J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2999-3012. doi: 10.1016/j.jcin.2023.10.028. Epub 2023 Oct 23.
- Rodes-Cabau J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol. 2022 Aug 16;80(7):681-693. doi: 10.1016/j.jacc.2022.05.005. Epub 2022 May 18.
- Cepas-Guillen P, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial. Circ Cardiovasc Interv. 2026 Mar;19(3):e016255. doi: 10.1161/CIRCINTERVENTIONS.125.016255. Epub 2026 Feb 2.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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