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

June 2, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATLAS TAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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