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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04914481
Acronym
ATLAS TAVI
Enrollment
1500
Registered
2021-06-04
Start date
2021-04-01
Completion date
2025-12-31
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-Flow, Low-Gradient Aortic Stenosis

Keywords

Aortic Stenosis, Low-Flow, Low-Gradient, TAVI

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.

Interventions

None listed

Sponsors

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All-cause mortality12 months

Secondary

MeasureTime frameDescription
Cardiovascular Mortality12 monthsIncidence 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 failure12 monthsIncidence 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.

Countries

Canada, Denmark, France, Germany, Israel, Netherlands, United Kingdom

Contacts

Primary ContactNiklas Schofer, MD
n.schofer@uke.de+49-40-7410-0
Backup ContactSebastian Ludwig, MD
se.ludwig@uke.de+49-40-7410-0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026