Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI

Recruiting now

Conditions studied: TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder, Aortic Stenosis, Permanent Pacemaker Implantation

In brief

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.

Key facts

Study ID

NCT07201363

Run by

Clinical Hospital Center Rijeka

People needed

102

Starts

2024-12-12

Expected to finish

2026-08-01

Last updated by the study team

2025-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written consent to participate in the trial
• Diagnosis of severe AS according to current European Society of Cardiology (ESC) guidelines for valvular heart disease

You may not qualify if…

• 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)

Where it is running

• Clinical Hospital Center Rijeka — Rijeka, Croatia, Croatia (enrolling)

Full record on ClinicalTrials.gov

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