Evaluation of BAV in Different Hemodynamic Entities of Severe AS

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT04053192
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Patients with Severe Aortic Stenosos who underwent BAV

Exclusion Criteria

• insufficient echocardiographic parameters before BAV

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-Procedure Hemodynamic Changes	24 - 72 h after procedure	dPmean, dPmax, AVA, Vmax, EF; Evaluation by using the first echocardiographic parameters after BAV / TAVR
All-cause Mortality	1-Year post BAV

Secondary Outcome Measures

Name	Time	Method
Number of patients with stroke	30 days after intervention	Evaluation by using the VARC-2 definition
Number of patients with myocardial infarction	30 days after intervention	Evaluation by using the VARC-2 definition
Number of patients with bleeding complications	30 days after intervention	Evaluation by using the VARC-2 definition
Number of patients with acute kidney injury	30 days after intervention	Evaluation by using the VARC-2 definition
Number of patients with vascular complications	30 days after intervention	Evaluation by using the VARC-2 definition

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Dusseldorf, Germany