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Low-Flow, Low-Gradient Aortic StenosisATLAS TAVINCT04914481

Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI

An observational study of Low-Flow, Low-Gradient Aortic Stenosis, run by Universitätsklinikum Hamburg-Eppendorf at 11 sites in 7 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low-Flow, Low-Gradient Aortic Stenosis
How many people
1,500 participants
Where
11 sitesin 7 countries
Study dates
1 Apr 2021to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • LFLG AS without non-contrast MSCT data on AVC

Trial locations and contacts

11 sites in 7 countries.

Niklas Schofer, MD contact

+49-40-7410-0

n.schofer@uke.de

Sebastian Ludwig, MD contact

+49-40-7410-0

se.ludwig@uke.de

11 sites in 7 countries

Germany3 sites, 3 recruiting

  • Kerckhoff-Klinik

    Bad Nauheim

    Won K Kim, MD

    Recruiting

  • University Heart and Vascular Center Hamburg

    Hamburg

    Niklas Schofer, MD

    Sebastian Ludwig, MD

    Recruiting

  • Heart Center Leipzig

    Leipzig

    Mohamed Abdel-Wahab, MD

    Recruiting

Other trials in Germany

Canada2 sites, 2 recruiting

  • Montreal Heart Institute

    Montreal

    Walid Ben Ali, MD

    Recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval

    Québec

    Marie-Annick Clavel, PhD

    Recruiting

Other trials in Canada

France2 sites, 2 recruiting

  • CHU de Lille

    Lille

    Augustin Coisne, MD

    Recruiting

  • Hôpital Bichat - Claude-Bernard

    Paris

    Marina Urena Alcazar, MD

    Recruiting

Other trials in France

Denmark1 site, 1 recruiting

  • Odense University Hospital

    Odense

    Jordi Dahl, MD

    Recruiting

Other trials in Denmark

Israel1 site, 1 recruiting

  • Rabin Medical Center

    Petah Tikva

    Uri Landes, MD

    Recruiting

Other trials in Israel

Netherlands1 site, 1 recruiting

  • Erasmus University Medical Centre

    Rotterdam

    Nicolas van Mieghem, MD

    Recruiting

Other trials in Netherlands

United Kingdom1 site, 1 recruiting

  • University of Edinburgh

    Edinburgh

    Mark Dweck, MD

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Keywords
Aortic Stenosis, Low-Flow, Low-Gradient, TAVI
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04914481
Study groupRoleWhat they receive
Classical Low-Flow, Low-Gradient Aortic StenosisClassical 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.
Paradoxical Low-Flow, Low-Gradient Aortic StenosisParadoxical 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.
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.
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: 12 months

Secondary outcomes (2)

  1. Cardiovascular Mortality

    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.

    Measured: 12 months

  2. Rehospitalizations for congestive heart failure

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start1 Apr 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914481
Sponsor's protocol ID
ATLAS TAVI
Acronym
ATLAS TAVI
Status last verified
Jun 2021
First submitted
2 Jun 2021
Last updated
4 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20720250

  • 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.

    PubMed 24076528

  • 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.

    PubMed 25236511

  • 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.

    PubMed 32502877

  • 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.

    PubMed 28886619

  • 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.

    PubMed 37192310

Questions about this trial

What is this clinical trial studying?

An observational study of Low-Flow, Low-Gradient Aortic Stenosis, run by Universitätsklinikum Hamburg-Eppendorf at 11 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Canada, France, Denmark, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Niklas Schofer, MD (+49-40-7410-0, n.schofer@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04914481, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.

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