NCT04053192

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
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 50 Years – 97 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
PROCEDURE	BAV	BAV
PROCEDURE	BAV + TAVR	BAV + TAVR
PROCEDURE	SAVR	Surgical aortic valve replacement (SAVR)

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2019-08-12
• Last updated: 2022-11-07

Locations

1 site across 1 country: Germany