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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT04914481

Collaborator

Institut universitaire de cardiologie et de pneumologie de Québec (Other)

1,500

Enrollment

Locations

Anticipated Duration (Months)

136.4

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low-Flow, Low-Gradient Aortic Stenosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

All-cause mortality [12 months]

Secondary Outcome Measures

Cardiovascular Mortality [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.
Rehospitalizations for congestive heart failure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Montreal Heart Institute	Montréal	Canada
2	Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval	Québec	Canada
3	Odense University Hospital	Odense	Denmark
4	CHU de Lille	Lille	France
5	Hôpital Bichat - Claude-Bernard	Paris	France
6	Kerckhoff-Klinik	Bad Nauheim	Germany
7	University Heart and Vascular Center Hamburg	Hamburg	Germany
8	Heart Center Leipzig	Leipzig	Germany
9	Rabin Medical Center	Petah Tikva	Israel
10	Erasmus University Medical Centre	Rotterdam	Netherlands
11	University of Edinburgh	Edinburgh	United Kingdom

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf
Institut universitaire de cardiologie et de pneumologie de Québec

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