Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI
NCT ID: NCT04914481
Last Updated: 2021-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2021-04-01
2025-12-31
Brief Summary
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Detailed Description
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The multicentric ATLAS TAVI Registry of LFLG AS patients, who underwent TAVI, assesses the impact of AVCd on outcome in these patients.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Marie-Annick Clavel, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada
Niklas Schofer, MD
Role: PRINCIPAL_INVESTIGATOR
University Heart and Vascular Center Hamburg, Hamburg, Germany
Sebastian Ludwig, MD
Role: PRINCIPAL_INVESTIGATOR
University Heart and Vascular Center Hamburg, Hamburg, Germany
Locations
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Montreal Heart Institute
Montreal, , Canada
Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval
Québec, , Canada
Odense University Hospital
Odense, , Denmark
CHU de Lille
Lille, , France
Hôpital Bichat - Claude-Bernard
Paris, , France
Kerckhoff-Klinik
Bad Nauheim, , Germany
University Heart and Vascular Center Hamburg
Hamburg, , Germany
Heart Center Leipzig
Leipzig, , Germany
Rabin Medical Center
Petah Tikva, , Israel
Erasmus University Medical Centre
Rotterdam, , Netherlands
University of Edinburgh
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Walid Ben Ali, MD
Role: primary
Marie-Annick Clavel, PhD
Role: primary
Jordi Dahl, MD
Role: primary
Augustin Coisne, MD
Role: primary
Marina Urena Alcazar, MD
Role: primary
Won K Kim, MD
Role: primary
Niklas Schofer, MD
Role: primary
Sebastian Ludwig, MD
Role: backup
Mohamed Abdel-Wahab, MD
Role: primary
Uri Landes, MD
Role: primary
Nicolas van Mieghem, MD
Role: primary
Mark Dweck, MD
Role: primary
References
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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.
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.
Ludwig S, Schofer N, Abdel-Wahab M, Urena M, Jean G, Renker M, Hamm CW, Thiele H, Iung B, Ooms JF, Wiessman M, Mogensen NSB, Longere B, Perrin N, Ben Ali W, Coisne A, Dahl JS, Van Mieghem NM, Kornowski R, Kim WK, Clavel MA. Transcatheter Aortic Valve Replacement in Patients With Reduced Ejection Fraction and Nonsevere Aortic Stenosis. Circ Cardiovasc Interv. 2023 May;16(5):e012768. doi: 10.1161/CIRCINTERVENTIONS.122.012768. Epub 2023 May 16.
Other Identifiers
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ATLAS TAVI
Identifier Type: -
Identifier Source: org_study_id
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