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: Recruiting
Location: See all (11) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Canada
Montreal Heart Institute
RECRUITING
Montreal
Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval
RECRUITING
Québec
Denmark
Odense University Hospital
RECRUITING
Odense
France
CHU de Lille
RECRUITING
Lille
Hôpital Bichat - Claude-Bernard
RECRUITING
Paris
Germany
Kerckhoff-Klinik
RECRUITING
Bad Nauheim
University Heart and Vascular Center Hamburg
RECRUITING
Hamburg
Heart Center Leipzig
RECRUITING
Leipzig
Israel
Rabin Medical Center
RECRUITING
Petah Tikva
Netherlands
Erasmus University Medical Centre
RECRUITING
Rotterdam
United Kingdom
University of Edinburgh
RECRUITING
Edinburgh
Contact Information
Primary
Niklas Schofer, MD
n.schofer@uke.de
+49-40-7410-0
Backup
Sebastian Ludwig, MD
se.ludwig@uke.de
+49-40-7410-0
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1500
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Leads: Universitätsklinikum Hamburg-Eppendorf