Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07201363

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

Led by Clinical Hospital Center Rijeka · Updated on 2025-10-06

102

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

C

Clinical Hospital Center Rijeka

Lead Sponsor

U

University of Rijeka, Medical Faculty

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to better understand the prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). Since new-onset CDs and the need for permanent pacemaker implantation (PPI) after TAVI can affect patient outcomes, this observational prospective trial studies the role of inflammation and fibrosis biomarkers in predicting these complications. Identifying patients at higher risk could help tailor treatment and monitoring strategies. Before the TAVI procedure, blood samples will be taken from participants to analyze various biomarkers related to inflammation and fibrosis, including C-reactive protein, procalcitonin, interleukin-6, calprotectin, lactate-dehydrogenase, ferritin, and others. A subgroup of 40 patients will have additional analysis of specific microRNAs linked to fibrosis and inflammation. Echocardiographic measures will assess cardiac damage and fibrosis. Patients will be monitored with electrocardiograms before, during hospitalization, and at a three-month follow-up to detect new-onset CDs or PPI. Participants will be grouped based on whether they develop new conduction disorders or receive a pacemaker during hospitalization and follow-up. The study will measure biomarker levels before TAVI and compare them with clinical outcomes. Ongoing ECG monitoring and echocardiographic assessments will help track heart function and conduction status. The trial is expected to continue until August 2026, involving detailed laboratory and imaging evaluations to understand the link between biomarkers and conduction complications after TAVI.

CONDITIONS

Brief Title

Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written consent to participate in the trial
  • Diagnosis of severe aortic stenosis according to current European Society of Cardiology guidelines
Not Eligible

You will not qualify if you...

  • 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
  • Acute myocardial infarction within three months before the procedure
  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At hospital admission before the procedure

Participants have blood samples collected and echocardiography performed before the TAVI procedure to analyze biomarkers of inflammation and fibrosis as well as cardiac damage related to aortic stenosis.

1 visit (in-person)

Monitoring

Duration - During hospitalization and up to 3 months after the procedure

Participants undergo electrocardiogram (ECG) monitoring during hospitalization and at a 3-month follow-up to detect new-onset conduction disorders or the need for permanent pacemaker implantation.

Hospitalization period plus 1 follow-up visit at 3 months

Trial Site Locations

Total: 1 location

1

Clinical Hospital Center Rijeka

Rijeka, Croatia, Croatia, 51000

Actively Recruiting

Loading map...

Research Team

G

Gordana Bačić, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

A Randomized Double-blind, Placebo-controlled, Multicenter T...

Aortic Stenosis

Actively Recruiting

139 locations

A Prospective Cohort Study of Bicuspid Case Selection and Va...

Aortic Stenosis

Actively Recruiting

21 locations

Artificial Intelligence-Based Assessment of Low-Gradient Aor...

Low-gradient Aortic Stenosis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Progression from compensated hypertrophy to failure in the pressure-overloaded human heart: structural deterioration and compensatory mechanisms.

Stefan Hein, Eyal Arnon, Sawa Kostin...

https://pubmed.ncbi.nlm.nih.gov/12600911

Incidence, Predictors, and Implications of Permanent Pacemaker Requirement After Transcatheter Aortic Valve Replacement.

Yasser Sammour, Amar Krishnaswamy, Arnav Kumar...

https://pubmed.ncbi.nlm.nih.gov/33478630