Using blood markers to predict conduction problems after TAVI
Official title: The Role of Inflammation and Fibrosis in the Development of Conduction Disorders After Transcatheter Aortic Valve Implantation
Run by Clinical Hospital Center Rijeka · NCT07201363 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Clinical Hospital Center Rijeka Academic / other |
| Locations | 1 site (Rijeka, Croatia) |
| Status | Recruiting |
| Started | December 12, 2024 |
| Main results expected | April 2026 |
| Study ends | August 2026 |
| Registry record updated | October 6, 2025 |
| Trial ID | NCT07201363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Clinical Hospital Center Rijeka
Rijeka, Croatia, Croatia Recruiting
Study contacts
- Study coordinator: Gordana Bačić, MD
- Email: gordana.bacic@uniri.hr
- Phone: +38551407320
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How TAVI affects gut bacteria in people with severe aortic stenosis
This will test whether transcatheter aortic valve implantation (TAVI) changes the gut microbiota and related blood markers in people with severe aortic stenosis.
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Comparing aspirin use versus no antithrombotic therapy after heart valve replacement
This study tests whether taking aspirin after heart valve replacement helps patients feel better compared to not taking any blood-thinning medicine.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
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Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Detecting cardiac amyloidosis in people with severe aortic valve narrowing
This study tests non-invasively whether imaging tests can find heart amyloidosis in patients with severe aortic stenosis who are being evaluated for valve replacement.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.