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Evaluation of BAV in Different Hemodynamic Entities of Severe AS

NCT ID: NCT04053192

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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High-Gradient Aortic Stenosis (HG-AS)

(Pmean \>40mmHg, AVA \<1cm\^2, Vmax \>4m/s)

BAV

Intervention Type PROCEDURE

BAV

BAV + TAVR

Intervention Type PROCEDURE

BAV + TAVR

SAVR

Intervention Type PROCEDURE

Surgical aortic valve replacement (SAVR)

Low-Flow-Low-Gradient Aortic Stenosis (LF-LG)

(Pmean \<40mmHg, AVA \<1cm\^2, Vmax \<4m/s, EF \<50%)

BAV

Intervention Type PROCEDURE

BAV

BAV + TAVR

Intervention Type PROCEDURE

BAV + TAVR

SAVR

Intervention Type PROCEDURE

Surgical aortic valve replacement (SAVR)

Paradoxe Low-Flow Low Gradient Aortic Stenosis (pLF-LG AS)

Pmean \<40mmHg, AVA \<1cm\^2, Vmax \< 4m/s, EF \>50%)

BAV

Intervention Type PROCEDURE

BAV

BAV + TAVR

Intervention Type PROCEDURE

BAV + TAVR

SAVR

Intervention Type PROCEDURE

Surgical aortic valve replacement (SAVR)

Interventions

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BAV

BAV

Intervention Type PROCEDURE

BAV + TAVR

BAV + TAVR

Intervention Type PROCEDURE

SAVR

Surgical aortic valve replacement (SAVR)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with Severe Aortic Stenosos who underwent BAV

Exclusion Criteria

* insufficient echocardiographic parameters before BAV
Minimum Eligible Age

50 Years

Maximum Eligible Age

97 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Zeus, MD

Role: PRINCIPAL_INVESTIGATOR

Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine

Locations

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Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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19-003 BAV

Identifier Type: -

Identifier Source: org_study_id

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