ACURATE Neo 2 瓣膜在中东地区症状性主动脉瓣狭窄患者中的应用 (BSC07)
2026年7月22日 更新者：Ceric Sàrl
本研究的目的是评估 ACURATE Neo2 在患有严重、症状性主动脉瓣狭窄的中东人群中的应用。
研究概览
详细说明
MENA-TAVI 研究是一项由研究者发起的前瞻性单组观察性试验。
因严重主动脉瓣狭窄需要干预而转诊或就诊的患者构成了源人群。 由介入心脏病专家和心血管外科医生组成的心脏团队将通过整合可用的临床数据、预测的 30 天死亡率、影响死亡率的个体因素（例如虚弱）以及估计的预期寿命和患者最终达到的愿望来评估患者关于经导管或外科主动脉瓣置换术的最佳治疗策略的共识。 计划进行 TAVI 的患者将接受资格筛选。 如果患者满足所有纳入标准但不符合排除标准，他们将被告知研究的目的和过程，并被要求参与和书面知情同意。 在同意的情况下，他们将接受 ACURATE neo2 主动脉生物假体治疗。
在出院时和 30 天时，将捕获构成主要安全终点的临床结果。 将在出院时和 30 天时获得额外的临床、程序和超声心动图数据，以评估次要终点。
研究类型
观察性的
注册 (实际的)
51
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aswān、埃及
- Magdy Yacoub heart center
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Cairo、埃及
- Ain Shams Specialized Hospital
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Cairo、埃及
- Badr hospital
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Jeddah、沙特阿拉伯
- King Fahad Armed Forces Hospital
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Riyadh、沙特阿拉伯
- King Fahad National Guard Hospital
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Riyadh、沙特阿拉伯
- National Guard Hospital - King Abdulaziz Medical City
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Beirut、黎巴嫩
- American University of Beirut
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
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
不
取样方法
非概率样本
研究人群
将招募来自中东人口的 100 名严重、有症状的主动脉瓣狭窄患者
描述
纳入标准：
如果满足以下所有条件，则主题将被包括在内：
- 主动脉瓣面积 (AVA) < 1cm2 或 AVA 与体表面积 (BSA) 指数 < 0.6 cm2/m2 定义的严重主动脉瓣狭窄患者，包括每搏量指数 (SVI) < 35ml 定义的低流量严重主动脉瓣狭窄/m2，通过超声心动图和侵入性测量的综合评估
- 受试者有症状（纽约心脏协会 (NYHA) 功能等级 > I 的心力衰竭症状、心绞痛或晕厥）
- 心脏团队认为患者处于高风险（STS-PROM（胸外科医师学会 - 死亡预测风险）评分 > 8）或中等（STS-PROM 评分 > 4）风险。
- 心脏团队同意患者的参与资格，并且经股动脉入路的 TAVR（经导管主动脉瓣置换术）(TAVR) 构成最合适的治疗方式，患者可能从中获益最多
- 主动脉环尺寸合适（面积范围：338-573 mm2 和周长范围：66-85 mm）基于 ECG 门控多层计算机断层扫描测量。 经食管超声心动图 (TEE) 和常规主动脉造影的结果应纳入解剖学评估（如有）
- 经多层螺旋计算机断层扫描血管造影和/或常规血管造影评估，动脉主髂股动脉轴适合经股动脉通路，最小通路血管直径≥ 6 mm
- 患者或其法律代表的书面知情同意书
- 患者了解试验的目的、潜在风险和益处，并愿意参与随访的所有部分
排除标准：
有下列情形之一的，不予录用：
- 非瓣膜性主动脉瓣狭窄
- 先天性主动脉瓣狭窄或单叶或二叶主动脉瓣
- 非钙化性获得性主动脉瓣狭窄
- 由于主动脉瓣环的大小或自体主动脉瓣钙化的程度或偏心度或主动脉或髂股动脉的迂曲，解剖结构不适合经股动脉经导管主动脉瓣植入术
- 紧急程序，包括心源性休克患者（低心输出量、血管升压药依赖、机械血流动力学支持）
- 左心室 (LV) 功能严重下降（射血分数 < 20%）
- 预先存在的人工心脏瓣膜处于主动脉位置
- 二尖瓣假体的存在
- 除经皮冠状动脉介入治疗 (PCI) 外的伴随计划手术
- 计划在 30 天内进行非心脏手术
- 手术后 30 天内中风。
- 手术后 30 天内发生心肌梗塞（2 型除外）
- 心脏内肿块、血栓或赘生物的证据
- 严重的凝血条件
- 无法耐受抗凝/抗血小板治疗
- 活动性细菌性心内膜炎或其他活动性感染
- 肥厚型心肌病
- 造影剂禁忌症或对镍钛诺过敏
- 参与另一项试验，这将导致干预的准备或执行或植入后管理偏离本协议
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
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 |
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全因死亡率
大体时间：手术后患者出院（最好是手术后 1-3 天）
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所有死亡报告
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手术后患者出院（最好是手术后 1-3 天）
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任何中风（致残和非致残）
大体时间：手术后患者出院（最好是手术后 1-3 天）
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所有中风事件
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手术后患者出院（最好是手术后 1-3 天）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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VARC-3 定义的技术成功
大体时间：手术后患者出院（最好是手术后 1-3 天）
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组合端点包括：
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手术后患者出院（最好是手术后 1-3 天）
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VARC-3 定义的设备成功
大体时间：患者出院后 30 天随访
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组合端点包括：
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患者出院后 30 天随访
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VARC-3 定义的早期安全性
大体时间：30天
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组合端点包括：
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30天
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根据 Valve 学术研究联盟 (VARC-2) 的定义，修改后的 30 天联合早期安全性和临床疗效
大体时间：30天
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30天
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VARC-3 定义的临床疗效
大体时间：30天
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组合端点包括：
组合端点包括：
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30天
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全因死亡率
大体时间：30天
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所有死亡报告
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30天
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瓣膜相关死亡率
大体时间：30天
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所有与阀门有关的死亡
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30天
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所有中风（缺血性、出血性）
大体时间：30天
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所有中风报告
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30天
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住院（或再住院）
大体时间：30天
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所有住院报告
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30天
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出血和输血（VARC3 类型 1 - 4）
大体时间：30天
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报告所有出血事件
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30天
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生物瓣功能障碍
大体时间：30天
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（结构性、非结构性、血栓形成、心内膜炎）：（1 至 3 期）
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30天
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具有临床意义的人工瓣膜血栓形成
大体时间：30天
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瓣膜相关血栓形成
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30天
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植入永久起搏器
大体时间：30天
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心脏起搏器植入
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30天
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房颤的发生
大体时间：30天
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心房颤动报告
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30天
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Mohamed BALGHITH, MD、King Fahad National Guard Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
- Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
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- Thanassoulis G, Campbell CY, Owens DS, Smith JG, Smith AV, Peloso GM, Kerr KF, Pechlivanis S, Budoff MJ, Harris TB, Malhotra R, O'Brien KD, Kamstrup PR, Nordestgaard BG, Tybjaerg-Hansen A, Allison MA, Aspelund T, Criqui MH, Heckbert SR, Hwang SJ, Liu Y, Sjogren M, van der Pals J, Kalsch H, Muhleisen TW, Nothen MM, Cupples LA, Caslake M, Di Angelantonio E, Danesh J, Rotter JI, Sigurdsson S, Wong Q, Erbel R, Kathiresan S, Melander O, Gudnason V, O'Donnell CJ, Post WS; CHARGE Extracoronary Calcium Working Group. Genetic associations with valvular calcification and aortic stenosis. N Engl J Med. 2013 Feb 7;368(6):503-12. doi: 10.1056/NEJMoa1109034.
- Rossebo AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Barwolf C, Holme I, Kesaniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2.
- Chakos A, Wilson-Smith A, Arora S, Nguyen TC, Dhoble A, Tarantini G, Thielmann M, Vavalle JP, Wendt D, Yan TD, Tian DH. Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond. Ann Cardiothorac Surg. 2017 Sep;6(5):432-443. doi: 10.21037/acs.2017.09.10.
- Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
- Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
- Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.
- Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
- Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.
- Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
- Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
- Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
- Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
- Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
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- Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.
- VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
- Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
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- Otto CM, Prendergast B. Aortic-valve stenosis--from patients at risk to severe valve obstruction. N Engl J Med. 2014 Aug 21;371(8):744-56. doi: 10.1056/NEJMra1313875. No abstract available.
- Tibazarwa KB, Volmink JA, Mayosi BM. Incidence of acute rheumatic fever in the world: a systematic review of population-based studies. Heart. 2008 Dec;94(12):1534-40. doi: 10.1136/hrt.2007.141309. Epub 2008 Jul 31.
- Otto CM. Calcific aortic stenosis--time to look more closely at the valve. N Engl J Med. 2008 Sep 25;359(13):1395-8. doi: 10.1056/NEJMe0807001. No abstract available.
- Katz R, Wong ND, Kronmal R, Takasu J, Shavelle DM, Probstfield JL, Bertoni AG, Budoff MJ, O'Brien KD. Features of the metabolic syndrome and diabetes mellitus as predictors of aortic valve calcification in the Multi-Ethnic Study of Atherosclerosis. Circulation. 2006 May 2;113(17):2113-9. doi: 10.1161/CIRCULATIONAHA.105.598086. Epub 2006 Apr 24.
- Owens DS, Katz R, Takasu J, Kronmal R, Budoff MJ, O'Brien KD. Incidence and progression of aortic valve calcium in the Multi-ethnic Study of Atherosclerosis (MESA). Am J Cardiol. 2010 Mar 1;105(5):701-8. doi: 10.1016/j.amjcard.2009.10.071.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年3月6日
初级完成 (实际的)
2026年5月31日
研究完成 (估计的)
2026年7月1日
研究注册日期
首次提交
2023年3月1日
首先提交符合 QC 标准的
2023年5月4日
首次发布 (实际的)
2023年5月8日
研究记录更新
最后更新发布 (实际的)
2026年7月23日
上次提交的符合 QC 标准的更新
2026年7月22日
最后验证
2026年7月1日
更多信息
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