Cardiac Damage and Conduction Disorders after Transcatheter Aortic Valve Implantation.
François Damas, Mai-Linh Nguyen Trung, Adriana Postolache...
https://pubmed.ncbi.nlm.nih.gov/38256543Actively Recruiting
Led by Clinical Hospital Center Rijeka · Updated on 2025-10-06
102
Participants Needed
1
Research Sites
17 weeks
Total Duration
C
Clinical Hospital Center Rijeka
Lead Sponsor
U
University of Rijeka, Medical Faculty
Collaborating Sponsor
This research aims to better understand the prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). Since new-onset CDs and the need for permanent pacemaker implantation (PPI) after TAVI can affect patient outcomes, this observational prospective trial studies the role of inflammation and fibrosis biomarkers in predicting these complications. Identifying patients at higher risk could help tailor treatment and monitoring strategies. Before the TAVI procedure, blood samples will be taken from participants to analyze various biomarkers related to inflammation and fibrosis, including C-reactive protein, procalcitonin, interleukin-6, calprotectin, lactate-dehydrogenase, ferritin, and others. A subgroup of 40 patients will have additional analysis of specific microRNAs linked to fibrosis and inflammation. Echocardiographic measures will assess cardiac damage and fibrosis. Patients will be monitored with electrocardiograms before, during hospitalization, and at a three-month follow-up to detect new-onset CDs or PPI. Participants will be grouped based on whether they develop new conduction disorders or receive a pacemaker during hospitalization and follow-up. The study will measure biomarker levels before TAVI and compare them with clinical outcomes. Ongoing ECG monitoring and echocardiographic assessments will help track heart function and conduction status. The trial is expected to continue until August 2026, involving detailed laboratory and imaging evaluations to understand the link between biomarkers and conduction complications after TAVI.
CONDITIONS
Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At hospital admission before the procedure
Participants have blood samples collected and echocardiography performed before the TAVI procedure to analyze biomarkers of inflammation and fibrosis as well as cardiac damage related to aortic stenosis.
1 visit (in-person)
Duration - During hospitalization and up to 3 months after the procedure
Participants undergo electrocardiogram (ECG) monitoring during hospitalization and at a 3-month follow-up to detect new-onset conduction disorders or the need for permanent pacemaker implantation.
Hospitalization period plus 1 follow-up visit at 3 months
Total: 1 location
1
Clinical Hospital Center Rijeka
Rijeka, Croatia, Croatia, 51000
Actively Recruiting
G
Gordana Bačić, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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