Using blood markers to predict conduction problems after TAVI
The Role of Inflammation and Fibrosis in the Development of Conduction Disorders After Transcatheter Aortic Valve Implantation
This study will test whether blood levels of inflammation and fibrosis markers taken before TAVI can help predict which patients with severe aortic stenosis will develop new conduction problems or need a permanent pacemaker.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Hospital Center Rijeka Academic / other |
| Locations | 1 site (Rijeka, Croatia) |
| Trial ID | NCT07201363 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Before the procedure, researchers will measure circulating biomarkers of inflammation and fibrosis from serum samples and perform transthoracic echocardiography with myocardial deformation analysis and cardiac damage staging. Patients will be followed for the occurrence of new-onset conduction disorders and need for permanent pacemaker implantation. The study will analyze whether pre-procedural biomarker levels are associated with post-TAVI conduction outcomes, accounting for clinical, electrocardiographic, anatomic, and procedural factors.
Who should consider this trial
Good fit: Adults with severe aortic stenosis scheduled for TAVI who can give written consent and do not have active infection, chronic inflammatory or autoimmune disease, recent MI or surgery, prior valve replacement, prior permanent pacemaker, active malignancy, significant liver dysfunction, or end-stage kidney disease are ideal candidates.
Not a fit: Patients who already have a permanent pacemaker, have active inflammatory or malignant disease, recent myocardial infarction or surgery, or end-stage kidney failure are excluded and would not benefit from these biomarker-based predictions.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify patients at higher risk for conduction problems after TAVI so they can tailor procedural planning and post-procedure monitoring.
How similar studies have performed: Previous research has linked inflammation and fibrosis biomarkers to cardiac remodeling and outcomes, but using them specifically to predict conduction disorders after TAVI is relatively novel with limited prior validation.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rijeka, Croatia
- Clinical Hospital Center Rijeka — Rijeka, Croatia, Croatia (Recruiting)
Study contacts
- Study coordinator: Gordana Bačić, MD
- Email: gordana.bacic@uniri.hr
- Phone: +38551407320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.