Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI (ATLAS TAVI)
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|ClinicalTrials.gov Identifier: NCT04914481|
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 4, 2021
|Condition or disease|
|Low-Flow, Low-Gradient Aortic Stenosis|
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 Type :||Observational|
|Estimated Enrollment :||1500 participants|
|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 :||April 1, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2025|
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.
- All-cause mortality [ Time Frame: 12 months ]
- Cardiovascular Mortality [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914481
|Contact: Niklas Schofer, MDfirstname.lastname@example.org|
|Contact: Sebastian Ludwig, MDemail@example.com|
|Montreal Heart Institute||Recruiting|
|Contact: Walid Ben Ali, MD|
|Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval||Recruiting|
|Contact: Marie-Annick Clavel, PhD|
|Odense University Hospital||Recruiting|
|Contact: Jordi Dahl, MD|
|CHU de Lille||Recruiting|
|Contact: Augustin Coisne, MD|
|Hôpital Bichat - Claude-Bernard||Recruiting|
|Contact: Marina Urena Alcazar, MD|
|Bad Nauheim, Germany|
|Contact: Won K Kim, MD|
|University Heart and Vascular Center Hamburg||Recruiting|
|Contact: Niklas Schofer, MD|
|Contact: Sebastian Ludwig, MD|
|Heart Center Leipzig||Recruiting|
|Contact: Mohamed Abdel-Wahab, MD|
|Rabin Medical Center||Recruiting|
|Petah Tikva, Israel|
|Contact: Uri Landes, MD|
|Erasmus University Medical Centre||Recruiting|
|Contact: Nicolas van Mieghem, MD|
|University of Edinburgh||Recruiting|
|Edinburgh, United Kingdom|
|Contact: Mark Dweck, MD|
|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|