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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

Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 4, 2021
Last Update Posted Date June 4, 2021
Actual Study Start Date April 1, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2021)
All-cause mortality [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 2, 2021)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Low-Flow, Low-Gradient Aortic Stenosis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 2, 2021)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Niklas Schofer, MD +49-40-7410-0 n.schofer@uke.de
Contact: Sebastian Ludwig, MD +49-40-7410-0 se.ludwig@uke.de
Listed Location Countries Canada,   Denmark,   France,   Germany,   Israel,   Netherlands,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04914481
Other Study ID Numbers ATLAS TAVI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators Institut universitaire de cardiologie et de pneumologie de Québec
Investigators
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
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date June 2021