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RECRUITING
NCT07201363

Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI

Sponsor: Clinical Hospital Center Rijeka

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

102

Start Date

2024-12-12

Completion Date

2026-08

Last Updated

2025-10-06

Healthy Volunteers

Yes

Interventions

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