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Completed

NCT Number: NCT04053192

Evaluation of BAV in Different Hemodynamic Entities of Severe AS

The purpose of this retrospective, observational study is to compare the profit of BAV and TAVI in different subtypes of serve aortic stenosis.

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Key information

Age range

50 year–97 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Severe Aortic Stenosos who underwent BAV

Exclusion criteria

  • insufficient echocardiographic parameters before BAV

Treatment and study plan

BAV

Procedure

BAV

BAV + TAVR

Procedure

BAV + TAVR

SAVR

Procedure

Surgical aortic valve replacement (SAVR)

Primary outcomes

  1. All-cause Mortality

    Time frame: 1-Year post BAV

  2. Post-Procedure Hemodynamic Changes

    Time frame: 24 - 72 h after procedure

    dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR

Secondary outcomes

  1. Number of patients with myocardial infarction

    Time frame: 30 days after intervention

    Evaluation by using the VARC-2 definition

  2. Number of patients with stroke

    Time frame: 30 days after intervention

    Evaluation by using the VARC-2 definition

  3. Number of patients with bleeding complications

    Time frame: 30 days after intervention

    Evaluation by using the VARC-2 definition

  4. Number of patients with acute kidney injury

    Time frame: 30 days after intervention

    Evaluation by using the VARC-2 definition

  5. Number of patients with vascular complications

    Time frame: 30 days after intervention

    Evaluation by using the VARC-2 definition

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis

Acronym: BAV

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 12, 2019
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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