작고 심각한 기능 장애가 있는 수술용 대동맥 생체 인공 삽입물의 치료를 위한 풍선 확장형 Edwards 판막과 자가 확장형 CoreValve Evolut R 또는 Evolut PRO 시스템의 비교. 'LYTEN' 시험
작고 심각한 기능 장애가 있는 수술용 대동맥 생체 인공 삽입물의 치료를 위한 풍선 확장형 Edwards 판막과 자체 확장형 CoreValve Evolut R 또는 Evolut PRO 시스템의 비교: 예비 전향적 무작위 무작위 시험. 'LYTEN' 시험
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V 4G5
- IUCPQ
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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. |
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다른: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of prothesis-patient mismatch (PPM) (valve performance)
기간: 30 days
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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
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Residual transvalvular gradient
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Transvalvular gradient.
기간: 1-year and yearly thereafter up to 10-year follow-up
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Maximal and mean transvalvular gradient |
1-year and yearly thereafter up to 10-year follow-up
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Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
기간: 30 days, 1 year and yearly thereafter up to 10-year follow-up
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Moderate or severe PPM; moderate-severe AR. |
30 days, 1 year and yearly thereafter up to 10-year follow-up
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Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
기간: 1 year and yearly thereafter up to 10-year follow-up
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Moderate-severe AR or severe PPM. |
1 year and yearly thereafter up to 10-year follow-up
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Clinical safety endpoints
기간: 30 days, 1 year and yearly thereafter up to 10-year follow-up
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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
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Exercise capacity
기간: 30 days, 1 year and yearly thereafter up to 10-year follow-up
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Exercise capacity as evaluated by the six-minute walk test |
30 days, 1 year and yearly thereafter up to 10-year follow-up
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Changes in LV hypertrophy
기간: 30 days , 1 year and yearly thereafter up to 10-year follow-up
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Changes in LV hypertrophy |
30 days , 1 year and yearly thereafter up to 10-year follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Josep Rodés-Cabau, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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