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

Recruiting

• Conditions: Low-Flow, Low-Gradient Aortic Stenosis

• Registration Number: NCT04914481
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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)

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Exclusion Criteria

• LFLG AS without non-contrast MSCT data on AVC

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	12 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

Erasmus University Medical Centre; 🇳🇱 Rotterdam, Netherlands

Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval; 🇨🇦 Québec, Canada

Montreal Heart Institute; 🇨🇦 Montréal, Canada

CHU de Lille; 🇫🇷 Lille, France

Odense University Hospital; 🇩🇰 Odense, Denmark

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

University Heart and Vascular Center Hamburg; 🇩🇪 Hamburg, Germany

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Hôpital Bichat - Claude-Bernard; 🇫🇷 Paris, France

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom