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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04053192
Other study ID # 19-003 BAV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date August 31, 2019

Study information

Verified date November 2022
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 97 Years
Eligibility Inclusion Criteria: - Patients with Severe Aortic Stenosos who underwent BAV Exclusion Criteria: - insufficient echocardiographic parameters before BAV

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
BAV
BAV
BAV + TAVR
BAV + TAVR
SAVR
Surgical aortic valve replacement (SAVR)

Locations

Country Name City State
Germany Division of Cardiology, Pulmonary Disease and Vascular Medicine Dusseldorf

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause Mortality 1-Year post BAV
Primary Post-Procedure Hemodynamic Changes dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR 24 - 72 h after procedure
Secondary Number of patients with myocardial infarction Evaluation by using the VARC-2 definition 30 days after intervention
Secondary Number of patients with stroke Evaluation by using the VARC-2 definition 30 days after intervention
Secondary Number of patients with bleeding complications Evaluation by using the VARC-2 definition 30 days after intervention
Secondary Number of patients with acute kidney injury Evaluation by using the VARC-2 definition 30 days after intervention
Secondary Number of patients with vascular complications Evaluation by using the VARC-2 definition 30 days after intervention
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