小型で重度の機能不全の外科用大動脈生体人工器官の治療における、バルーン拡張型エドワーズ弁と自己拡張型 CoreValve Evolut R または Evolut PRO システムの比較。 「LYTEN」トライアル
小型で重度の機能不全の外科用大動脈バイオプロテーゼの治療のためのバルーン拡張型エドワーズ弁と自己拡張型 CoreValve Evolut R または Evolut PRO システムの比較：パイロット前向き無作為化試験。 「LYTEN」トライアル
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Quebec
-
Québec、Quebec、カナダ、G1V 4G5
- IUCPQ
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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. |
|
他の：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of prothesis-patient mismatch (PPM) (valve performance)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Transvalvular gradient.
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Josep Rodés-Cabau, MD、Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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