NCT07201363 Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
| NCT ID | NCT07201363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinical Hospital Center Rijeka |
| Condition | TAVI(Transcatheter Aortic Valve Implantation) |
| Study Type | OBSERVATIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2026-04 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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)