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Evaluation of BAV in Different Hemodynamic Entities of Severe AS

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04053192
Acronym
BAV
Enrollment
166
Registered
2019-08-12
Start date
2018-06-01
Completion date
2019-08-31
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Balloon Aortic Valvuloplasty, Severe Aortic Valve Stenosis, Surgical aortic valve replacement (SAVR)

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.

Interventions

PROCEDUREBAV

BAV

PROCEDUREBAV + TAVR

BAV + TAVR

PROCEDURESAVR

Surgical aortic valve replacement (SAVR)

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 97 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Severe Aortic Stenosos who underwent BAV

Exclusion criteria

* insufficient echocardiographic parameters before BAV

Design outcomes

Primary

MeasureTime frameDescription
All-cause Mortality1-Year post BAV
Post-Procedure Hemodynamic Changes24 - 72 h after proceduredPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR

Secondary

MeasureTime frameDescription
Number of patients with bleeding complications30 days after interventionEvaluation by using the VARC-2 definition
Number of patients with myocardial infarction30 days after interventionEvaluation by using the VARC-2 definition
Number of patients with vascular complications30 days after interventionEvaluation by using the VARC-2 definition
Number of patients with acute kidney injury30 days after interventionEvaluation by using the VARC-2 definition
Number of patients with stroke30 days after interventionEvaluation by using the VARC-2 definition

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026