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

Last updated: June 2, 2021
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04914481
ATLAS TAVI
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • LFLG AS without non-contrast MSCT data on AVC

Study Design

Total Participants: 1500
Study Start date:
April 01, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Montreal Heart Institute

    Montréal,
    Canada

    Active - Recruiting

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

    Québec,
    Canada

    Active - Recruiting

  • Odense University Hospital

    Odense,
    Denmark

    Active - Recruiting

  • CHU de Lille

    Lille,
    France

    Active - Recruiting

  • Hôpital Bichat - Claude-Bernard

    Paris,
    France

    Active - Recruiting

  • Kerckhoff-Klinik

    Bad Nauheim,
    Germany

    Active - Recruiting

  • University Heart and Vascular Center Hamburg

    Hamburg,
    Germany

    Active - Recruiting

  • Heart Center Leipzig

    Leipzig,
    Germany

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva,
    Israel

    Active - Recruiting

  • Erasmus University Medical Centre

    Rotterdam,
    Netherlands

    Active - Recruiting

  • University of Edinburgh

    Edinburgh,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.