Clinical trial NCT04053192: Evaluation of BAV in Different Hemodynamic Entities of Severe AS
Official title: Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Balloon Aortic Valvuloplasty
Severe Aortic Valve Stenosis
Surgical aortic valve replacement (SAVR)
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 166
Sex: ALL
Minimum age (years): 50
Maximum age (years): 97
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the heart failure program of the University of 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.

Eligibility criteria: Inclusion Criteria:

* Patients with Severe Aortic Stenosos who underwent BAV

Exclusion Criteria:

* insufficient echocardiographic parameters before BAV

Primary outcomes:
measure: All-cause Mortality
timeFrame: 1-Year post BAV
measure: Post-Procedure Hemodynamic Changes
timeFrame: 24 - 72 h after procedure
Secondary outcomes:
measure: Number of patients with myocardial infarction
timeFrame: 30 days after intervention
measure: Number of patients with stroke
timeFrame: 30 days after intervention
measure: Number of patients with bleeding complications
timeFrame: 30 days after intervention
measure: Number of patients with acute kidney injury
timeFrame: 30 days after intervention
measure: Number of patients with vascular complications
timeFrame: 30 days after intervention
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Div. of Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
name: Tobias Zeus, MD
role: PRINCIPAL_INVESTIGATOR
References: