Recruiting

Observational Study

Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Code:

NCT04914481

Conditions

Low-Flow, Low-Gradient Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Low-Flow, Low-Gradient Aortic Stenosis

Study ID

NCT04914481

Start date

Apr 1, 2021

Status verified date

Jun, 2021

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • All-cause mortality [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Niklas Schofer, MD

+49-40-7410-0n.schofer@uke.de

Sebastian Ludwig, MD

+49-40-7410-0se.ludwig@uke.de

Locations

Montreal Heart Institute

Recruiting

Montréal, Canada

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

Recruiting

Québec, Canada

More Information

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Last update posted

Jun 4, 2021

Last verified

Jun, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf on 2021-06-04.