RECRUITINGOBSERVATIONAL

Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI

The Role of Inflammation and Fibrosis in the Development of Conduction Disorders After Transcatheter Aortic Valve Implantation

About This Trial

Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes. The goal of this observational prospective trial is to investigate the role of pre-procedural values of systemic biomarkers of inflammation and fibrosis in the prediction of new-onset CDs and permanent pacemaker implantation (PPI) in patients undergoing the TAVI procedure.

Who May Be Eligible (Plain English)

Who May Qualify: - Written consent to participate in the trial - Diagnosis of severe AS according to current European Society of Cardiology (ESC) guidelines for valvular heart disease Who Should NOT Join This Trial: - Acute infectious disease - Chronic inflammatory or autoimmune conditions (where your immune system attacks your own body) - Corticosteroid or other immunosuppressive therapy - Active malignant disease - Liver disease accompanied by dysfunction - Permanent pacemaker implanted previously - An acute myocardial infarction within three months before the procedure - A surgical procedure within three months before the procedure - Previous surgical or transcatheter aortic valve replacement/implantation - End-stage chronic kidney disease (eGFR \<15 ml/min) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Written consent to participate in the trial * Diagnosis of severe AS according to current European Society of Cardiology (ESC) guidelines for valvular heart disease Exclusion Criteria: * Acute infectious disease * Chronic inflammatory or autoimmune disease * Corticosteroid or other immunosuppressive therapy * Active malignant disease * Liver disease accompanied by dysfunction * Permanent pacemaker implanted previously * An acute myocardial infarction within three months before the procedure * A surgical procedure within three months before the procedure * Previous surgical or transcatheter aortic valve replacement/implantation * End-stage chronic kidney disease (eGFR \<15 ml/min)

Treatments Being Tested

DIAGNOSTIC_TEST

Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples

In all patients, peripheral venous blood samples will be collected before the TAVI procedure for analysis and calculation of prespecified inflammatory and fibrosis biomarkers. In a subpopulation of 40 individuals, four specific microRNAs (miR-21, miR-29b, miR-155, and miR-146b) will be additionally analysed. The level of each biomarker will be correlated with rates of new-onset TAVI-related CDs and compared between patients with detected and patients without detected new-onset CDs.

DIAGNOSTIC_TEST

Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS

The echocardiographic stage of extravalvular cardiac damage related to AS and myocardial deformation parameters will be analysed in each patient before TAVI procedure and compared between the group with detected new-onset CDs and the group without new-onset CDs with a goal to examine their predictive value for the development of TAVI-related CDs.

Locations (1)

Clinical Hospital Center Rijeka

Rijeka, Croatia, Croatia