Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-29 @ 1:55 PM
Study NCT ID:
NCT06096428
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2023-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemolysis During Pulsed-field and Radiofrequency Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006461', 'term': 'Hemolysis'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood drawing for hemolysis assessment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythrocyte (red blood cells, RBC) microparticles', 'timeFrame': 'One day after the procedure', 'description': 'The concentration of erythrocyte microparticles /µL. Analysis using flow cytometry, as the concentration of total erythrocyte mictoparticles in platelet-rich plasma.'}, {'measure': 'Cell free hemoglobin', 'timeFrame': 'One day after the procedure', 'description': 'The concentration of cell-free hemoglobin, using ELISA measurement, in g/L'}], 'secondaryOutcomes': [{'measure': 'Lactate-dehydrogenase', 'timeFrame': 'One day after the procedure', 'description': 'The concentration of lactate-dehydrogenase (µkat/L)'}, {'measure': 'Haptoglobin', 'timeFrame': 'One day after the procedure', 'description': 'The concentration of haptoglobin (g/L)'}, {'measure': 'Indirect bilirubin', 'timeFrame': 'One day after the procedure', 'description': 'The concentration of indirect bilirubin (µmol/L)'}, {'measure': 'Reticulocytes', 'timeFrame': 'One day after the procedure', 'description': 'The absolute concentration of reticulocytes'}, {'measure': 'Immature reticulocyte fraction (IRF)', 'timeFrame': 'One day after the procedure', 'description': 'The percentage of immature reticulocytes of all reticulocytes (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Hemolysis', 'Pulsed-field Ablation']}, 'referencesModule': {'references': [{'pmid': '23273528', 'type': 'RESULT', '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 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': '33933412', 'type': 'RESULT', '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. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.'}, {'pmid': '35647644', 'type': 'RESULT', 'citation': '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': '37608882', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDespite 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.\n\nThe 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.\n\nIn 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).\n\nIn 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.\n\nBlood 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).\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic atrial fibrillation indicated for catheter ablation\n* willingness to participate\n\nExclusion Criteria:\n\n* pregnancy\n* any known malignant or non-malignant hematological disorder\n* malignancy\n* age \\> 75 years\n* any disease associated with hemolysis\n* hemoglobin concentration less than 100 g/L\n* liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT06096428', 'briefTitle': 'Hemolysis During Pulsed-field and Radiofrequency Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'The Assessment of Intravascular Peri-procedural Hemolysis During Catheter Ablation for Atrial Fibrillation Using Radiofrequency and Pulsed-field Energy', 'orgStudyIdInfo': {'id': 'PFA HEMOLYSIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulsed-field group', 'description': 'Patients will undergo catheter ablation for atrial fibrillation using pulsed-field energy', 'interventionNames': ['Device: Pulsed-field ablation']}, {'label': 'Radiofrequency group', 'description': 'Patients will undergo catheter ablation using radiofrequency energx', 'interventionNames': ['Device: Radiofrequency ablation']}], 'interventions': [{'name': 'Pulsed-field ablation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Pulsed-field group']}, {'name': 'Radiofrequency ablation', 'type': 'DEVICE', 'description': 'Pulmonary vein isolation will be done using radiofrequency catheter (Qdot, Biosense-Webster) and generator of radiofrequency energy (nGEN, Biosense-Webster).', 'armGroupLabels': ['Radiofrequency group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Starting after the publication of results', 'ipdSharing': 'YES', 'description': 'Data will be shared based on individual request', 'accessCriteria': 'By request on PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}