Evaluation of BAV in Different Hemodynamic Entities of Severe AS

Aortic Valve Stenosis Clinical Trial

— BAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053192
• Other study ID #: 19-003 BAV
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

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