Hemolysis During Pulsed-field and Radiofrequency Ablation

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096428
• Other study ID #: PFA HEMOLYSIS
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: September 2023
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 PF and RF energy. Sixty consecutive patients indicated for catheter ablation for AF according to the standard recommendation (symptomatic paroxysmal or non-paroxysmal AF) will be enrolled. Consecutive patients as they are scheduler for procedure will be enrolled without randomization. In 40 patients (20 paroxysmal and 20 non-paroxysmal), the ablation will be done using PF energy, and in 20 patients using RF energy.

In all patients, intracardiac echocardiography (Accunav, Siemens, Germany) and fluoroscopy will be used for navigation. The procedures will be done as it is currently routinely done in the EP lab. In RF patients, 4 vascular access will be used (one for 10-pole catheter placed into the coronary sinus, one for intracardiac echocardiography probe, and 2 for transseptal sheaths). Two transseptal punctures will be done under the guidance of intracardiac echocardiography using SL1 sheaths (Abbott, USA). One transseptal access will be used for diagnostic circular mapping catheter (Lasso, Biosense-Webster, USA), the other for the ablation catheter. The RF ablation will be performed using SmartTouch or QDot ablation catheters (both Biosense-Webster, USA); however, ablation will be driven by the ablation index even if QDot catheter is used. The RF ablation will be performed using ablation index (400-450 on anterior-superior aspects and 350-400 on posterior aspects of PVs), the QDot Plus (high-power short-duration) regimen won´t be used. The goal will be to achieve the entrance and exit block of all 4 PVs. In non-paroxysmal patients, additional ablations could be done at the discretion of the treating physician (fractionated singnals, lines).

In the PF patients, two vascular access will be obtained. The first will be used for intracardiac echocardiography, the second for the transseptal sheath. Transseptal puncture will be done also using SL1 sheath (Abbott, USA), and using over-the-wire technique, this sheath will be exchanged by the 16-F Faradrive sheath (BSCI, USA). The ablation then will be done using pentaspline ablation catheter (Farawave, Boston Scientific). Four application of pulsed-field energy in basket configuration, and 4 application in flower configuration will be applied to each pulmonary vein. Additional pulsed-field energy application could be added if the signal in PV are present. In non-paroxysmal patients, additional pulsed-field energy application could be applied on the discretion of the operator on the posterior wall, or mitral isthmus.

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 in all three samples 1) using flow cytometry (by means of measurement of "erythrocyte microparticles detected by the presence of antigens glycophorin A and Annexin V) and 2) using ELISA method (assessment of "cell free hemoglobin " concentration). Additionelly, standard biochemistry and blood count analysis will be done from the T1 and T3 samples (the concentration of lactate dehydrogenase, haptoglobin, indirect bilirubin, reticulocytes, and immature reticulocyte fraction).

Primary hypothesis is that the level of hemolysis will be higher after PF ablation compared to RF ablation. Since no studies were published on the hemolysis either during RF or PF ablation, no reliable power calculation can be done.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hemolysis

Intervention

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 ablation
Pulmonary vein isolation will be done using radiofrequency catheter (Qdot, Biosense-Webster) and generator of radiofrequency energy (nGEN, Biosense-Webster).

Locations

Country	Name	City	State
Czechia	Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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

Outcome

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