Clinical trial NCT04914481: Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low-Flow, Low-Gradient Aortic Stenosis
Keywords: Aortic Stenosis
Low-Flow, Low-Gradient
TAVI
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
First posted: 2021-06-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Mortality
timeFrame: 12 months
measure: Rehospitalizations for congestive heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval
city: Odense
country: Denmark
facility: Odense University Hospital
city: Lille
country: France
facility: CHU de Lille
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centre
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada
name: Marie-Annick Clavel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart and Vascular Center Hamburg, Hamburg, Germany
name: Niklas Schofer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart and Vascular Center Hamburg, Hamburg, Germany
name: Sebastian Ludwig, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.