Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI (ATLAS TAVI)
2021年6月2日 更新者：Universitätsklinikum Hamburg-Eppendorf
AnaTomic Stenosis Severity Derived From Computed Tomography as a Prognostic Marker in Patients With Low-flow Low-gradient Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC).
The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.
研究概览
地位
招聘中
详细说明
Aortic valve calcification (AVC) as assessed by MSCT is highly correlated with aortic stenosis (AS) severity and, thus, has become an important tool for diagnosing severe AS, especially in patients with low-flow low-gradient aortic stenosis (LFLG AS). Moreover, in medically treated AS patients AVC is directly associated with poor prognosis. In contrast, the prognostic benefit of eliminating AS by Transcatheter Aortic Valve Implantation (TAVI) in patients with LFLG AS seems to be larger in patients with high AVC density (AVCd) compared to those with low AVCd, at least in "classical" (low EF) LFLG AS. Hence, we hypothesize that AVCd might be a valuable marker for treatment response among TAVI patients with LFLG AS, who are known to suffer from poor outcome even after elimination of AS.
The multicentric ATLAS TAVI Registry of LFLG AS patients, who underwent TAVI, assesses the impact of AVCd on outcome in these patients.
研究类型
观察性的
注册 (预期的)
1500
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。
学习联系方式
- 姓名：Niklas Schofer, MD
- 电话号码：+49-40-7410-0
- 邮箱：n.schofer@uke.de
学习地点
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Odense、丹麦
- 招聘中
- Odense University Hospital
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接触：
- Jordi Dahl, MD
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Petah Tikva、以色列
- 招聘中
- Rabin Medical Center
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接触：
- Uri Landes, MD
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Montréal、加拿大
- 招聘中
- Montreal Heart Institute
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接触：
- Walid Ben Ali, MD
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Québec、加拿大
- 招聘中
- Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval
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接触：
- Marie-Annick Clavel, PhD
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Bad Nauheim、德国
- 招聘中
- Kerckhoff-Klinik
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接触：
- Won K Kim, MD
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Hamburg、德国
- 招聘中
- University Heart and Vascular Center Hamburg
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Leipzig、德国
- 招聘中
- Heart Center Leipzig
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接触：
- Mohamed Abdel-Wahab, MD
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Lille、法国
- 招聘中
- CHU de Lille
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接触：
- Augustin Coisne, MD
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Paris、法国
- 招聘中
- Hôpital Bichat - Claude-Bernard
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接触：
- Marina Urena Alcazar, MD
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Edinburgh、英国
- 招聘中
- University of Edinburgh
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接触：
- Mark Dweck, MD
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Rotterdam、荷兰
- 招聘中
- Erasmus University Medical Centre
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接触：
- Nicolas van Mieghem, MD
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This is a retrospective, investigator-initiated, multicenter registry including patients, who underwent TAVI for classical or paradoxical LFLG AS with available non-contrast MSCT data on AVC.
Furthermore, data will be gathered for the control groups of patients with high-gradient AS, who underwent TAVI, and heart failure patients with concomitant AS, who underwent medical treatment.
MSCT data will not be mandatory for control groups.
描述
Inclusion Criteria:
- age ≥18 years
- patient gave written informed consent for data acquisition and transfer
- for LFLG AS: -- available non-contrast MSCT data on aortic valve calcification (AVC, Agatston Units)
Exclusion Criteria:
- LFLG AS without non-contrast MSCT data on AVC
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
队列和干预
团体/队列 |
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Classical Low-Flow, Low-Gradient Aortic Stenosis
Classical Low-Flow, Low-Gradient Aortic Stenosis is defined as valve area <1 cm2, mean gradient <40 mmHg, ejection fraction <50% and stroke volume index (SVi) ≤35 mL/m2 by resting transthoracic echocardiography.
Dobutamine stress echocardiography is not mandatory for the definition of classical LFLG AS.
All patients in this subgroup underwent TAVI and have available data on aortic valve calcification.
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Paradoxical Low-Flow, Low-Gradient Aortic Stenosis
Paradoxical Low-Flow, Low-Gradient Aortic Stenosis is defined as valve area <1 cm2, mean gradient <40 mmHg, ejection fraction ≥50% and SVi ≤35 mL/m2 by resting transthoracic echocardiography.
All patients in this subgroup underwent TAVI and have available data on aortic valve calcification.
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High-Gradient Aortic Stenosis (Control group)
High-Gradient Aortic Stenosis is defined as valve area <1 cm2 and mean gradient >40 mmHg by resting transthoracic echocardiography.
All patients in this subgroup underwent TAVI.
Data on aortic valve calcification is not mandatory for this control group.
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Conservative treatment (Control group)
The subgroup includes all patients with (severe or non-severe) aortic stenosis, who underwent conservative treatment.
Data on aortic valve calcification is not mandatory for this control group.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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全因死亡率
大体时间：12个月
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12个月
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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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Cardiovascular Mortality
大体时间：12 months
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Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
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12 months
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Rehospitalizations for congestive heart failure
大体时间：12 months
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Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews or hospital records.
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12 months
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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。
调查人员
- 首席研究员：Marie-Annick Clavel, PhD、Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada
- 首席研究员：Niklas Schofer, MD、University Heart and Vascular Center Hamburg, Hamburg, Germany
- 首席研究员：Sebastian Ludwig, MD、University Heart and Vascular Center Hamburg, Hamburg, Germany
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
- 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.
- Cueff C, Serfaty JM, Cimadevilla C, Laissy JP, Himbert D, Tubach F, Duval X, Iung B, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Measurement of aortic valve calcification using multislice computed tomography: correlation with haemodynamic severity of aortic stenosis and clinical implication for patients with low ejection fraction. Heart. 2011 May;97(9):721-6. doi: 10.1136/hrt.2010.198853. Epub 2010 Aug 18.
- Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA, Michelena HI, Cueff C, Larose E, Capoulade R, Vahanian A, Enriquez-Sarano M. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol. 2013 Dec 17;62(24):2329-38. doi: 10.1016/j.jacc.2013.08.1621. Epub 2013 Sep 24.
- Clavel MA, Pibarot P, Messika-Zeitoun D, Capoulade R, Malouf J, Aggarval S, Araoz PA, Michelena HI, Cueff C, Larose E, Miller JD, Vahanian A, Enriquez-Sarano M. Impact of aortic valve calcification, as measured by MDCT, on survival in patients with aortic stenosis: results of an international registry study. J Am Coll Cardiol. 2014 Sep 23;64(12):1202-13. doi: 10.1016/j.jacc.2014.05.066.
- Ludwig S, Gossling A, Waldschmidt L, Linder M, Bhadra OD, Voigtlander L, Schafer A, Deuschl F, Schirmer J, Reichenspurner H, Blankenberg S, Schafer U, Westermann D, Seiffert M, Conradi L, Schofer N. TAVR for low-flow, low-gradient aortic stenosis: Prognostic impact of aortic valve calcification. Am Heart J. 2020 Jul;225:138-148. doi: 10.1016/j.ahj.2020.03.013. Epub 2020 Apr 8.
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)
2021年4月1日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2025年12月31日
研究注册日期
首次提交
2021年6月2日
首先提交符合 QC 标准的
2021年6月2日
首次发布 (实际的)
2021年6月4日
研究记录更新
最后更新发布 (实际的)
2021年6月4日
上次提交的符合 QC 标准的更新
2021年6月2日
最后验证
2021年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.