Atrial Fibrillation Clinical Trial
Official title:
The Assessment of Hemolysis and Renal Functions During and After Catheter Ablation for Atrial Fibrillation Using Pulsed-field Energy
Verified date | December 2023 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the project is to assess hemolysis and renal function after catheter ablation for atrial fibrillation using pulsed-field energy. Hemolysis will be determined using the concentration of red blood cell microparticles at the end of the ablation (when all ablation were done, before sheath removal). Hemoglobinuria will be assessed one day after the procedure. Renal functions will be assessed one and three day after the procedure using standard parameters (creatinine, urea). The goal is to assses the acute worsening fo renal functions after pulsed-field ablation in relation to the number of PF applications, and to the degree of immediate post-procedural hemolysis.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | August 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - symptomatic paroxysmal or non-paroxysmal atrial fibrillation Exclusion Criteria: - known hematologic disoders - disorders associated with increased hemolysis - known significant hepatic disease - patient in permanent hemodialysis |
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
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
Wolf PA, Benjamin EJ, Belanger AJ, Kannel WB, Levy D, D'Agostino RB. Secular trends in the prevalence of atrial fibrillation: The Framingham Study. Am Heart J. 1996 Apr;131(4):790-5. doi: 10.1016/s0002-8703(96)90288-4. No abstract available. — 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 | Red blood cell microparticles | The concentration of red blood cell microparticles in the plasma assessed using flow cytometry | day of the procedure - at the end of the procedure | |
Primary | Hemoglobinuria | The concentration of hemoglobin in urine | One day after the procedure | |
Primary | Creatinine three days | The cooncentration of creatinine three days after ablation | 3 days after the procedure | |
Secondary | Lactate dehydrogenase | The concentration of lactate dehydrogenase at the end of ablation | the day of the procedure - at the end of the procedure | |
Secondary | Haptoglobin | The concentration of haptoglobin at the end of ablation | the day of the procedure - at the end of the procedure | |
Secondary | Creatinine one day | The concentration of creatinine one day after ablation | one day after the procedure |
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