RecruitingNCT07201363

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

Sponsor

Clinical Hospital Center Rijeka

Enrollment

102 participants

Start Date

Dec 12, 2024

Study Type

OBSERVATIONAL

Conditions

Aortic Stenosis TAVI(Transcatheter Aortic Valve Implantation)Conduction Disorder Permanent Pacemaker Implantation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria10

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)

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Interventions

DIAGNOSTIC_TESTBiomarkers 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_TESTTransthoracic 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.