Atrial Fibrillation Clinical Trial
Official title:
The Assessment of Intravascular Peri-procedural Hemolysis During Catheter Ablation for Atrial Fibrillation Using Radiofrequency and Pulsed-field Energy
Verified date | September 2023 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hemolysis during and after catheter ablation will be compared between catheter ablation performed using radiofrequency and pulsed-field energy. Consecutive patients indicated for catheter ablation for AF will be enrolled, catheter ablation will be done using standard catheters (Qdot, Biosense Webster for RF, and Farapulse, Boston-Scientific for PF). Blood samples will be drawn at the beginning of ablation (T1), at the end of ablation (T2), and one day after the procedure (T3). Hemolysis will be analyzed using flow cytometry, ELISA and standard biochemistry and compared between RF and PF patients, Primary hypothesis is that hemolysis level will be higher after PF ablation compared to RF ablation.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - symptomatic atrial fibrillation indicated for catheter ablation - willingness to participate Exclusion Criteria: - pregnancy - any known malignant or non-malignant hematological disorder - malignancy - age > 75 years - any disease associated with hemolysis - hemoglobin concentration less than 100 g/L - liver cirrhosis |
Country | Name | City | State |
---|---|---|---|
Czechia | Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady | Prague |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic |
Czechia,
Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais — View Citation
Liu D, Li Y, Zhao Q. Effects of Inflammatory Cell Death Caused by Catheter Ablation on Atrial Fibrillation. J Inflamm Res. 2023 Aug 17;16:3491-3508. doi: 10.2147/JIR.S422002. eCollection 2023. — View Citation
Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. — View Citation
Zoni-Berisso M, Filippi A, Landolina M, Brignoli O, D'Ambrosio G, Maglia G, Grimaldi M, Ermini G. Frequency, patient characteristics, treatment strategies, and resource usage of atrial fibrillation (from the Italian Survey of Atrial Fibrillation Managemen — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erythrocyte (red blood cells, RBC) microparticles | The concentration of erythrocyte microparticles /µL. Analysis using flow cytometry, as the concentration of total erythrocyte mictoparticles in platelet-rich plasma. | One day after the procedure | |
Primary | Cell free hemoglobin | The concentration of cell-free hemoglobin, using ELISA measurement, in g/L | One day after the procedure | |
Secondary | Lactate-dehydrogenase | The concentration of lactate-dehydrogenase (µkat/L) | One day after the procedure | |
Secondary | Haptoglobin | The concentration of haptoglobin (g/L) | One day after the procedure | |
Secondary | Indirect bilirubin | The concentration of indirect bilirubin (µmol/L) | One day after the procedure | |
Secondary | Reticulocytes | The absolute concentration of reticulocytes | One day after the procedure | |
Secondary | Immature reticulocyte fraction (IRF) | The percentage of immature reticulocytes of all reticulocytes (%) | One day after the procedure |
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