RecruitingNot Applicable

Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI

Croatia102 participantsStarted 2024-12-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pre-procedural levels of C-reactive protein (mg/L) and calprotectin (mg/L)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural level of interleukin-6 (ng/L)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural levels of procalcitonin (µg/L) and ferritin (µg/L)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural level of transforming growth factor-β1(pg/ml)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural level of lactate-dehydrogenase (U/I)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural C-reactive protein to albumin ratio and index of systemic immuno-inflammation values

Timeframe: At hospital admission, before TAVI procedure

Trial details

NCT IDNCT07201363

SponsorClinical Hospital Center Rijeka

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Gordana Bačić, MD

+38551407320 gordana.bacic@uniri.hr

View on ClinicalTrials.gov More TAVI(Transcatheter Aortic Valve Implantation) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pre-procedural levels of C-reactive protein (mg/L) and calprotectin (mg/L)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural level of interleukin-6 (ng/L)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural levels of procalcitonin (µg/L) and ferritin (µg/L)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural level of transforming growth factor-β1(pg/ml)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural level of lactate-dehydrogenase (U/I)

Timeframe: At hospital admission, before TAVI procedure

Pre-procedural C-reactive protein to albumin ratio and index of systemic immuno-inflammation values

Timeframe: At hospital admission, before TAVI procedure