Evaluation of BAV in Different Hemodynamic Entities of Severe AS

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. 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Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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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