Hemolysis During Pulsed-field and Radiofrequency Ablation

NCT06096428 | Unknown

• 1 other identifier: PFA HEMOLYSIS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Hemolysis; Pulsed-field Ablation

Outcome Measures

Primary Outcomes (2)

• 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

• Cell free hemoglobin

  The concentration of cell-free hemoglobin, using ELISA measurement, in g/L

  One day after the procedure

Secondary Outcomes (5)

• Lactate-dehydrogenase

  One day after the procedure

• Haptoglobin

  One day after the procedure

• Indirect bilirubin

  One day after the procedure

• Reticulocytes

  One day after the procedure

• Immature reticulocyte fraction (IRF)

  One day after the procedure

Study Arms (2)

Pulsed-field group

Patients will undergo catheter ablation for atrial fibrillation using pulsed-field energy

Device: Pulsed-field ablation

Radiofrequency group

Patients will undergo catheter ablation using radiofrequency energx

Device: Radiofrequency ablation

Interventions

Pulsed-field ablation DEVICE

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.

Pulsed-field group

Radiofrequency ablation DEVICE

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

Radiofrequency group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic paroxysmal or non-paroxysmal atrial fibrillation indicated according current guideliens for the cathter ablation of atrial fibrillation, i.e. pulmonary vein isolation

You may qualify if:

• symptomatic atrial fibrillation indicated for catheter ablation
• willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (4)

• 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 Management [ISAF] study). Am J Cardiol. 2013 Mar 1;111(5):705-11. doi: 10.1016/j.amjcard.2012.11.026. Epub 2012 Dec 28.

  PMID: 23273528 RESULT

• 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. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

  PMID: 33933412 RESULT

• 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 P, Petru J, Chun J, Roten L, Futing A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, Neuzil P; MANIFEST-PF Cooperative. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022 Sep 1;24(8):1256-1266. doi: 10.1093/europace/euac050.

  PMID: 35647644 RESULT

• 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.

  PMID: 37608882 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood drawing for hemolysis assessment

MeSH Terms

Conditions

Atrial Fibrillation; Hemolysis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 23, 2023
• Study Start: November 15, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Starting after the publication of results
• Access Criteria: By request on PI

Locations

CZ (1)