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

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ClinicalTrials.gov Identifier: NCT04914481
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 4, 2021
Sponsor:
Collaborator:
Institut universitaire de cardiologie et de pneumologie de Québec
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease
Low-Flow, Low-Gradient Aortic Stenosis

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.
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.
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.



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cardiovascular Mortality [ Time Frame: 12 months ]
    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.

  2. Rehospitalizations for congestive heart failure [ Time Frame: 12 months ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914481


Contacts
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Contact: Niklas Schofer, MD +49-40-7410-0 n.schofer@uke.de
Contact: Sebastian Ludwig, MD +49-40-7410-0 se.ludwig@uke.de

Locations
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Canada
Montreal Heart Institute Recruiting
Montréal, Canada
Contact: Walid Ben Ali, MD         
Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval Recruiting
Québec, Canada
Contact: Marie-Annick Clavel, PhD         
Denmark
Odense University Hospital Recruiting
Odense, Denmark
Contact: Jordi Dahl, MD         
France
CHU de Lille Recruiting
Lille, France
Contact: Augustin Coisne, MD         
Hôpital Bichat - Claude-Bernard Recruiting
Paris, France
Contact: Marina Urena Alcazar, MD         
Germany
Kerckhoff-Klinik Recruiting
Bad Nauheim, Germany
Contact: Won K Kim, MD         
University Heart and Vascular Center Hamburg Recruiting
Hamburg, Germany
Contact: Niklas Schofer, MD         
Contact: Sebastian Ludwig, MD         
Heart Center Leipzig Recruiting
Leipzig, Germany
Contact: Mohamed Abdel-Wahab, MD         
Israel
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Uri Landes, MD         
Netherlands
Erasmus University Medical Centre Recruiting
Rotterdam, Netherlands
Contact: Nicolas van Mieghem, MD         
United Kingdom
University of Edinburgh Recruiting
Edinburgh, United Kingdom
Contact: Mark Dweck, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Institut universitaire de cardiologie et de pneumologie de Québec
Investigators
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Principal Investigator: Marie-Annick Clavel, PhD Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada
Principal Investigator: Niklas Schofer, MD University Heart and Vascular Center Hamburg, Hamburg, Germany
Principal Investigator: Sebastian Ludwig, MD University Heart and Vascular Center Hamburg, Hamburg, Germany
Publications:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04914481    
Other Study ID Numbers: ATLAS TAVI
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Aortic Stenosis
Low-Flow, Low-Gradient
TAVI
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction