Hemolysis During Pulsed-field and Radiofrequency Ablation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Catheter ablation presents the most effective treatment for atrial fibrillation (AF). It consists of the electrical isolation of the pulmonary veins. Several kinds of ablation energies can be used for the ablation. So far, the most often kind of energy was radiofrequency (RF) energy that leads to thermal destruction of the cardiac tissue. Newly, pulsed-field (PF) energy was developed for catheter ablation of AF. The use of PF energy consists in ultra-short, high-power application of electrical impulses that lead to fast, non-thermal cardiac tissue destruction.
Despite significant advantages, such as tissue selectivity, short procedure duration, and high durability of ablated lesions, the use of PF energy could also have other adverse effects. Recently, renal failure due to accelerated peri-procedural hemolysis in patients with pre-existed renal disease was described after PF ablation for AF.
The aim of the project is to assess and compare the level of hemolysis during catheter ablation for AF using RF or PF energy. Sixty consecutive patients indicated for catheter ablation for AF according to the standard recommendation (symptomatic paroxysmal or non-paroxysmal AF) will be enrolled. In 40 patients (20 paroxysmal and 20 non-paroxysmal), the ablation will be done using PF energy, and in 20 patients using RF energy. The procedure will be done as it is routinely done in the EP lab. In RF patients, CARTO Qdot ablation catheter will be used for ablation (Biosense-Webster), and in PF, pentaspline pulsed-field ablation catheter (Farapulse, Boston Scientific) will be used. In all patients, intracardiac echocardiography (Accunav, Siemens) and fluoroscopy will be used for navigation, and 10-polar diagnostic catheter (Dynamic, Boston Scientific) will be placed in the coronary sinus for stimulation. Consecutive patients as they are scheduler for procedure will be enrolled without randomization. Blood samples will be taken at the beginning of the procedure from the femoral vein (T1), at the end of the procedure after ablation lesions completion (T2), and one day after the procedure (T3). Hemolysis will be assessed using several methods: 1) flow cytometry, by means of measurement of "erythrocyte microparticles "(detected by the presence of antigens glycophorin A and Annexin V), 2) ELISA method, assessment of "cell free hemoglobin ", ad 3) standard biochemistry and blood count analysis (reticulocytes, morphologic changes of erythrocytes, concentration of lactate-dehydrogenase). Primary hypothesis is that the level of hemolysis will be higher after PF ablation compared to RF ablation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pulsed-field group Patients will undergo catheter ablation for atrial fibrillation using pulsed-field energy |
Device: Pulsed-field ablation
Pulsed-field ablation will be done using pentaspline catheter (Farawave, Boston Scientific) and pulsed-field energy generator. The goal will be achieve of electrical isolation of pulmonary veins.
|
| Radiofrequency group Patients will undergo catheter ablation using radiofrequency energx |
Device: Radiofrequency ablation
Pulmonary vein isolation will be done using radiofrequency catheter (Qdot, Biosense-Webster) and generator of radiofrequency energy (nGEN, Biosense-Webster).
|
Outcome Measures
Primary Outcome Measures
- Erythrocyte microparticles [One day after the procedure]
The concentration of erythrocyte microparticles. Analysis using flow cytometry, as percentage of the total mictoparticles in platelet-rich plasma
- Cell free hemoglobin [One day after the procedure]
The concentration of cell-free hemoglobin, using ELISA measurement, in g/L
Secondary Outcome Measures
- Reticulocytes [One day after the procedure]
The concentration of reticulocytes, as percentage of all erythrocytes
- Lactate-dehydrogenase [One day after the procedure]
The concentration of lactate-dehydrogenase, in international units / liter
- Morphology of erythrocytes [One day after dhe procedure]
Changes in morphology of erythrocytes determined by optical microscopy, semictantitative
Eligibility Criteria
Criteria
Inclusion Criteria:
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symptomatic atrial fibrillation indicated for catheter ablation
-
willingness to participate
Exclusion Criteria:
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pregnancy
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any known malignant or non-malignant hematological disorder
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malignancy
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age > 75 years
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any disease associated with hemolysis
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hemoglobin concentration less than 100 g/L
-
liver cirhosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady | Prague | Czechia | 10034 |
Sponsors and Collaborators
- Charles University, Czech Republic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PFA HEMOLYSIS