Brief Title
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
Official Title
Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis
Brief Summary
The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.
Detailed Description
The Balloon Aortic Valvuloplasty (BAV) is a catheter-based intervention, which can be used for dilatation of serve aortic stenosis. With this minimally invasive intervention an increase of the aortic valve area (AVA) and cardiac ejection fraction (EF), decrease of transvalvular gradients and ultimately a symptom relief should be achieved. The required effect is temporary and a definitive treatment should be aspired in suitable patients. Therefor Transcatheter Aortic Valve Replacement (TAVR) is available. Following the guidelines of the European Society of Cardiology for the management of valvular heart disease from 2017, the aortic stenosis can be divided into different subtypes by using haemodynamic parameters: High-gradient AS (HG-AS), Low-Flow-Low-Gradient AS (LFLG-AS) and paradoxical Low-Flow-Low-Gradient (pLFLG-AS). Patients with LFLG-AS are suspected to have a poorer prognosis when treated curative as well as when treated palliative medicamentous, because these patients show coronary and myocardial restrictions more frequently in addition to the valvular disease. The aim of the study is to compare safety and effectiveness of balloon aortic valvuloplasty as a bridging therapy and transcatheter aortic valve replacement as a definitive treatment in HG-AS, LFLG-AS and pLFLG-AS patients to verify whether the subtypes of aortic stenosis profit equally from these interventions.
Study Type
Observational
Primary Outcome
All-cause Mortality
Secondary Outcome
Number of patients with myocardial infarction
Condition
Aortic Valve Stenosis
Intervention
BAV
Study Arms / Comparison Groups
High-Gradient Aortic Stenosis (HG-AS)
Description: (Pmean >40mmHg, AVA <1cm^2, Vmax >4m/s)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
166
Start Date
June 1, 2018
Completion Date
August 31, 2019
Primary Completion Date
August 31, 2019
Eligibility Criteria
Inclusion Criteria: - Patients with Severe Aortic Stenosos who underwent BAV Exclusion Criteria: - insufficient echocardiographic parameters before BAV
Gender
All
Ages
50 Years - 97 Years
Accepts Healthy Volunteers
No
Contacts
Tobias Zeus, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04053192
Organization ID
19-003 BAV
Responsible Party
Principal Investigator
Study Sponsor
Heinrich-Heine University, Duesseldorf
Study Sponsor
Tobias Zeus, MD, Principal Investigator, Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Verification Date
December 2019