MedTrace Logo

Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI

NCT07201363 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • University of Rijeka, Medical Faculty

    collaborator UNKNOWN

  • Clinical Hospital Center Rijeka

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-04-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • Croatia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201363 on ClinicalTrials.gov