An observational study in TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder and Aortic Stenosis, sponsored by Clinical Hospital Center Rijeka. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Clinical Hospital Center Rijeka · Observational
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.
Transcatheter aortic valve implantation (TAVI) has become an established therapeutic option for the management of severe aortic stenosis (AS) in patients at all levels of surgical risk. Significant improvements in procedural safety and efficacy, along with growing operator experience, have led to a reduction of periprocedural complications. However, the incidence of new-onset conduction disorders (CDs) remains relatively high. This represents a cause for concern, especially regarding the trend of expanding TAVI indication towards younger and lower-risk patients.
Since certain CDs and PPI after TAVI are associated with poorer outcomes, identifying patients at high risk for new-onset CDs is paramount. With careful pre-procedural planning and modification of procedural steps, it is possible to avoid the occurrence of CDs in some patients. After the procedure, more intensive and prolonged electrocardiographic (ECG) monitoring should be applied in patients at high risk. A substantial number of TAVI-related CD predictors have been identified and should be evaluated in every patient, including clinical, electrocardiographic, anatomic, and procedural-related factors.
The process of inflammation and fibrosis plays a significant role in the pathogenesis of degenerative AS, causing not only valvular changes, but also myocardial and conduction system remodeling, with limited research addressing the latter. Circulating biomarkers of inflammation and fibrosis, reflecting the underlying pathological changes of the conduction system, could potentially be correlated with the risk of TAVI-related CDs. Those biomarkers have not been investigated as predictors of the aforementioned disorders so far. Routinely and widely available inflammatory biomarkers could be used in everyday clinical practice as additional predictors for the development of TAVI-related CDs and consequently contribute to an individualized approach in planning the procedure. In accordance with certain more specific and complex biomarkers, analysis of this correlation could also contribute to understanding and clarifying the role of inflammation and fibrosis in the pathogenesis of new-onset CDs in patients undergoing the TAVI procedure.
Trial objective: 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 with severe AS undergoing TAVI procedure.
Methodology: This is an observational prospective trial that will include a minimum of 102 consecutive patients with severe AS hospitalized in Clinical Hospital Center Rijeka for a planned TAVI procedure, according to the previous Heart Team decision. In all patients, peripheral venous blood samples will be collected before the procedure for analysis and calculation of inflammatory and fibrosis biomarkers (C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6), calprotectin, lactate-dehydrogenase (LD), ferritin, CRP/albumin ratio (CAR), index of systemic immuno-inflammation (SII), and transforming growth factor-β1 (TGF- β1). In a patient subpopulation of 40 individuals, four specific microRNAs (miR-21, miR-29b, miR-155, and miR-146b) involved in the regulation of fibrosis and inflammation, will be additionally analyzed. Pre-procedural echocardiographic parameters to assess the extent of extravalvular cardiac damage related to AS and myocardial deformation analysis as a non-invasive marker of fibrosis will be evaluated and correlated with rates of new-onset TAVI-related CDs. The electrocardiogram (ECG) will be analysed before and consecutively after the procedure, during hospitalization, and at a 3-month follow-up. Patients will be assigned to a group with or without new-onset CD, whether a previously defined CD or PPI was recorded during the index hospitalization and follow-up period.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 102 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Clinical Hospital Center Rijeka is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The trial will include a minimum 102 consecutive patients with severe AS hospitalized in Clinical Hospital Centre Rijeka for a planned TAVI procedure, according to the previous Heart Team decision.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group will include patients with new-onset CD or PPI detected during the index hospitalization and a 3-month follow-up period.
Diagnostic Test: Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples · Diagnostic Test: Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
The group will include patients without new-onset CD or PPI detected during the index hospitalization and a 3-month follow-up period.
Diagnostic Test: Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples · Diagnostic Test: Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
In all patients, peripheral venous blood samples will be collected before the TAVI procedure for analysis and calculation of prespecified inflammatory and fibrosis biomarkers. In a subpopulation of 40 individuals, four specific microRNAs (miR-21, miR-29b, miR-155, and miR-146b) will be additionally analysed. The level of each biomarker will be correlated with rates of new-onset TAVI-related CDs and compared between patients with detected and patients without detected new-onset CDs.
Also known as: C-reactive protein (CRP), Procalcitonin (PCT), Interleukin-6 (IL-6), CRP/albumin ratio (CAR), Index of Systemic Immuno-inflammation (SII), Lactate-dehydrogenase (LD), Micro ribonucleic acids (miRNAs), Ferritin, Transforming Growth Factor-β1 (TGF-β1), Calprotectin
The echocardiographic stage of extravalvular cardiac damage related to AS and myocardial deformation parameters will be analysed in each patient before TAVI procedure and compared between the group with detected new-onset CDs and the group without new-onset CDs with a goal to examine their predictive value for the development of TAVI-related CDs.
Also known as: Stage of extravalvular cardiac damage related to AS, Left ventricle global longitudinal strain (LV GLS), LV apical to basal strain ratio, Right ventricle global longitudinal strain (RV GLS), Right ventricle free wall strain (RV FWS), Myocardial work index (MWI)
Pre-procedural levels of C-reactive protein (mg/L) and calprotectin (mg/L)
The levels of C-reactive protein (mg/L) and calprotectin (mg/L) will be compared between the group with new-onset CDs and the group without new-onset CDs. The goal is to determine if their levels differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs. For calprotectin analysis, an additional serum blood sample will be collected from every patient, and stored at -80 °C for subsequent analysis by the ELISA method.
Time frame: At hospital admission, before TAVI procedure
Pre-procedural level of interleukin-6 (ng/L)
The levels of interleukin-6 (ng/L) will be compared between the group with new-onset CDs and the group without new-onset CDs. The goal is to determine if the levels of interleukin-6 differ significantly between the two groups and to examine its predictive value for the development of TAVI-related CDs
Time frame: At hospital admission, before TAVI procedure
Pre-procedural levels of procalcitonin (µg/L) and ferritin (µg/L)
The levels of procalcitonin (µg/L) and ferritin (µg/L) will be compared between the group with new-onset CDs and the group without new-onset CDs. The goal is to determine if their levels differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs.
Time frame: At hospital admission, before TAVI procedure
Pre-procedural level of transforming growth factor-β1(pg/ml)
The levels of transforming growth factor-β1(pg/ml) will be compared between the group with new-onset CDs and the group without new-onset CDs. The goal is to determine if the levels of TGF-β1 differ significantly between the two groups and to examine its predictive value for the development of TAVI-related CDs. For TGF-β1 analysis, an additional serum blood sample will be collected from every patient, and stored at -80 °C for subsequent analysis by the ELISA method.
Time frame: At hospital admission, before TAVI procedure
Pre-procedural level of lactate-dehydrogenase (U/I)
The levels of lactate-dehydrogenase (U/I) will be compared between the group with new-onset CDs and the group without new-onset CDs. The goal is to determine if the levels of lactate-dehydrogenase differ significantly between the two groups and to examine its predictive value for the development of TAVI-related CDs
Time frame: At hospital admission, before TAVI procedure
Pre-procedural C-reactive protein to albumin ratio and index of systemic immuno-inflammation values
The values of C-reactive protein to albumin ratio and index of systemic immuno-inflammation will be calculated and compared between the group with new-onset CDs and the group without new-onset CDs. The goal is to determine if their values differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs.
Time frame: At hospital admission, before TAVI procedure
Pre-procedural levels of microRNAs (miR-21, miR-29b, miR-155, and miR-146b) in a subpopulation of 40 patients
The levels of four microRNAs included in the regulation of the fibrosis and inflammation process will be analysed and compared between the subgroup with new-onset CDs (20 pts) and the subgroup without new-onset CDs (20 pts). A group of ten healthy individuals will be additionally included for microRNAs analysis. Serum blood samples will be collected at the time of hospitalization, before the TAVI procedure, and stored at -80 °C for subsequent analysis by polymerase chain reaction (PCR). The goal is to determine if their levels differ significantly between the two groups and analyse their correlation with other biomarkers of inflammation and fibrosis
Time frame: At hospital admission, before TAVI procedure
Myocardial deformation parameters
Left ventricle global longitudinal strain (%), right ventricle global longitudinal strain (%) and right ventricle free wall strain (%) will be compared between the group with new-onset CDs and the group without new-onset CDs, with a goal to determine if they differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs
Time frame: At hospital admission, before TAVI procedure
Left ventricle apical to basal strain ratio
Values of the left ventricle apical to basal strain ratio will be compared between the group with new-onset CDs and the group without new-onset CDs, with a goal to determine if they differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs
Time frame: At hospital admission, before TAVI procedure
Myocardial work index (mmHg%)
Values of myocardial work index (mmHg%) will be compared between the group with new-onset CDs and the group without new-onset CDs, with a goal to determine if they differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs
Time frame: At hospital admission, before TAVI procedure
Stage of extravalvular cardiac damage (0-4)
Echocardiographic stages of extravalvular cardiac damage (0-4) related to AS will be compared between the group with new-onset CDs and the group without new-onset CDs, with a goal to determine if they differ significantly between the two groups and to examine their predictive value for the development of TAVI-related CDs
Time frame: At hospital admission, before TAVI procedure
Plan to share: No
Started Dec 2024 (actual). Primary completion is estimated for Apr 2026, 16 months after the start.
Of 189 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 140. This study's planned 16 months is below that.
Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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