Our technology - pulsed field ablation or "PFA" - represents a fundamentally different and improved therapy. doi: 10.4149/gpb_2012_003, 8. Europace. Procedure workflow and electrophysiological findings at the time of ablation, peri-procedural complications, and operator learning curves are described. FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation.
First experience with pulsed field ablation as routine treatment for Objectives This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF. Choose this option to get remote access when outside your institution. At the time of the study, Operator 1 had more than 10 years of experience (senior) and Operator 2 had less than 5 years of experience (junior). The learning curves of the two operators who performed > 20 procedures showed a negligible variation of performance over time and practice did not significantly predict procedure time [Operator 1 (senior): R2 = 0.034, p = 0.35; Operator 2 (junior): R2 = 0.004, p = 0.73]. PLoS One. 8600 Rockville Pike The structure of the waveforms was a hierarchical set of microsecond-scale biphasic pulses, unsynchronized to cardiac rhythm (Figure 1).
First patients treated in study of Globe pulsed field ablation system Talk with your doctor and family members or friends about deciding to join a study. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation Vivek Reddy (left) and team use the Globe system to perform pulsed field ablation. Unintentional ablation of atrial tissue can occur, accurate catheter alignment to the PV ostium and PV axis should be ensured. Three-dimensional electrophysiological voltage maps after pulmonary vein isolation were performed with pulsed field ablation. Therefore, we cannot draw conclusions on the mid or long-term efficacy of PFA. Procedure times are homogeneous, and LA dwell time is short. Methods: PersAFOne is a single-arm study evaluating biphasic, bipolar PFA using a multispline catheter for PVI and LAPW ablation under intracardiac echocardiographic guidance. Eu Heart J.
Introduction. Condition (s): Paroxysmal Atrial Fibrillation Last Updated: September 2, 2022 Active, not recruiting. Intracardiac Echocardiography: A Handbook for Electrophysiologists. Reddy VY, Neuzil P, Anic A. doi: 10.1007/s10840-016-0172-z, 5. doi: 10.1093/europace/euv224, PubMed Abstract | CrossRef Full Text | Google Scholar, 4. Each application consisted of five pulses. Pulmonary vein isolation (PVI) with a "single-shot" pulsed-field ablation (PFA) catheter results in excellent PVI durability and acceptable safety with a low one-year rate of atrial arrhythmia recurrence in paroxysmal atrial fibrillation (AF) patients, according to data pooled from three clinical trials. PV remapping, performed in 110 patients at 93.0 30.1 days, demonstrated durable PVI in 84.8% of PVs (64.5% of patients), and 96.0% of PVs (84.1% of patients) treated with the optimized biphasic energy PFA waveform. (2007) 6:3748. VANCOUVER, British Columbia, November 08, 2022--Kardium Inc. announces the successful first-in-human study of its next generation Globe Pulsed Field System to treat atrial fibrillation (AF . government site. In addition, ablation beyond the PVs (left atrial posterior wall ablation) is feasible. (2020) 76:30656. After high-density left atrial (LA) bipolar voltage mapping, all PVs were individually isolated using a 13 Fr steerable sheath and a pentaspline PFA over-the-wire catheter. The mean number of applications per pulmonary vein (PV) was 8.1 0.6. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. For permissions, please e-mail: journals.permissions@oup.com. Acute isolation was achieved in 100% of the PVs after 12.4 1.0 applications per patient (3.26 0.5 applications/PV), with a total average procedure time of 67 10.5 min. Procedures without 3D mapping lasted a mean of 52.3 16.6 min. An important feature of pulse field ablation is its tissue specificity. Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF). See below. Prior to ablation, patients suffered predominantly from paroxysmal AF (80.0%). Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Product Manufactured in and Exported from the U.S.: Number of Participants with of Primary Adverse Events (PAEs) [TimeFrame:Within one week (7 days) post-procedure], Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure [TimeFrame:91-365 Days], Number of Participants who Achieved Acute Procedural Success [TimeFrame:91-365 Days], Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure [TimeFrame:91-365 Days], Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [TimeFrame:Baseline, Month 3, 6 and 12], Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF), Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI), Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD, Able and willing to comply with all pre-, post- and follow-up testing and requirements, AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause, Previous left atrium (LA) ablation or surgery, Participant known to require ablation outside the PV region (example. 2022 Aug;32(6):378-387. doi: 10.1016/j.tcm.2021.07.006.
FARAPULSE Receives European Approval To Commercialize Its Leading Lattice-tip focal ablation catheter that toggles between radiofrequency and pulsed field energy to treat atrial fibrillation: a first-in-human trial. A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE).
Initial experience with pulsed field ablation for atrial fibrillation The safety and efficacy of pulsed field ablation(PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) will be studied using ring-shaped pulsed field ablation catheter ClinicalTrials.gov. Do not use an Oxford Academic personal account. PFA using a straight tip, extra-sti! Recent . The average number of PFA applications to the posterior wall was 19.2 8.7. The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. PVI using PFA for paroxysmal AF is safe for the bronchial system. J Cardiovasc Electrophysiol. Nine patients had a left common ostium, for which the mean number of applications was 11.1 2.7. These utilized different catheters and waveform protocols which makes the comparison of outcomes difficult. Access to content on Oxford Academic is often provided through institutional subscriptions and purchases.
Journal of Cardiovascular Electrophysiology: "Pulsed field ablation for pulmonary vein isolation in the treatment of atrial fibrillation." British Journal of Clinical Pharmacology : "One . For these procedures, 3D electroanatomic mapping was used (EnSite Precision, Abbott, or Rhythmia HDx, Boston Scientific, Marlborough, MA, USA) and the 3D anatomy was created with a high-density mapping catheter (Advisor HD grid, Abbott, or IntellaMap Orion, Boston Scientific) or with the Farawave (Farapulse) catheter. VANCOUVER, British Columbia--(BUSINESS WIRE)-- Kardium Inc. announces the successful first-in-human study of its next generation Globe Pulsed Field System to treat atrial fibrillation (AF) using pulsed field ablation (PFA) therapy.Working with Dr. Vivek Reddy 1 from Mount Sinai Hospital (New York, USA), and Prof. Petr Neuil and Dr. Jan Petr from Na Homolce Hospital (Prague, Czech . Here you will find options to view and activate subscriptions, manage institutional settings and access options, access usage statistics, and more. @article{Reinsch2022CerebralSA, title={Cerebral safety after pulsed field ablation for paroxysmal atrial fibrillation. Cardiovasc. For permissions please email: Journals.permissions@oup.com. doi: 10.1016/j.jacep.2021.02.014, 11.
The Effect of Pulsed-field and Radiofrequency Ablation on Platelet THBS1, a fatty acid-related metabolic gene, can promote the development of laryngeal cancer. 1 Key Resources Product Specification Sheet Clinical Compendium SIGN UP FOR NEWSLETTER For librarians and administrators, your personal account also provides access to institutional account management. In 2020, the same group reported the 1-year outcomes of the first-in-human, non-randomized feasibility trials, which enrolled a total of 121 patients across three centers (10). doi: 10.1093/europace/euac044, 15. PFA is very tissue selective. All rights reserved. Kawamura I, Neuzil P, Shivamurthy P, Kuroki K, Lam J, Musikantow D, Chu E, Turagam MK, Minami K, Funasako M, Petru J, Choudry S, Miller MA, Langan MN, Whang W, Dukkipati SR, Koruth JS, Reddy VY. Europace. In 30 patients (mean 63 years; 47% male), uncomplicated PFA was performed, with all PVs acutely isolated.
Pulsed Field Ablation: 29 Clinical Trials, Page 1 of 3 - TrialBulletin.com 18. Thermal LA ablation, like cryo can cause bronchial damage, like hemorrhagic lesions, atrio-bronchial fistula and severe bleedings.
Pulsed field ablation of cardiac arrhythmia - All About Cardiovascular A Study for Treatment of Paroxysmal Atrial Fibrillation NCT04524364 After ablation, mapping was repeated to assess lesion formation. In addition, the lack of remapping data after ablation prevents us from drawing conclusions on the durability of PFA lesions (10). Device: Pulsed Field Ablation (PFA) Therapy Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac . Kardium Inc. (kardium.com) is a rapidly growing medical solutions company that has developed an advanced atrial fibrillation (AF) treatment system: the Globe Pulsed Field System. The median fluoroscopy time was 26min. Materials and methods: We investigated 100 patients treated for symptomatic AF using the FARAWAVE PFA catheter (Farapulse, Menlo Park, CA, USA) between July 2021 and March 2022. Learning curve for pulsed field ablation (of operators who performed > 20 procedures). Pulsed field ablation (PFA) is a nonthermal energy that may provide safety advantages over radiofrequency ablation (RFA). Future studies are warranted to determine long-term efficacy and safety outcomes. Clinical course was uneventful, no patient had chest discomfort, coughing or hemoptysis. Received: 01 June 2022; Accepted: 17 October 2022;Published: 08 November 2022. This was managed by applying pressure and compression bandages. In one patient with roof-dependent flutter, a roof line was intentionally created. doi: 10.1161/CIRCEP.119.008192, 14. Atrial ablation lines can easily be created. A LA bipolar voltage 3D map was created. The Author(s) 2022. On ICE, contact was assessed by observing visual contact of the catheter in the basket and flower positions (see Figure 1A), and on fluoroscopy when further advancement of the catheter was not possible (no contrast was used). Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation. Pre- and post-ablation, phrenic nerve function was assessed. Electrophysiological findings following pulmonary vein isolation using radiofrequency catheter guided by contact-force and second-generation cryoballoon: lessons from repeat ablation procedures. The only complications observed were two cases of bleeding at the site of percutaneous access. Kuck KH, Brugada J, Frnkranz A, Metzner A, Ouyang F, Chun J, et al. For general information, Learn About Clinical Studies. PVI using PFA for paroxysmal AF in a "real-world" setting is safe and feasible. Procedure times are homogeneous, and LA dwell time is short. Methods and results Pre- and post-ablation, phrenic nerve function was assessed. Unintentional ablation of atrial tissue can occur, accurate catheter alignment to the PV ostium and axis should be ensured. 32 Articles, This article is part of the Research Topic, https://www.frontiersin.org/articles/10.3389/fcvm.2022.959186/full#supplementary-material, Creative Commons Attribution License (CC BY). In 12 patients (40%), small amounts of blood clots without active bleeding were seen in multiple segments. He was also a proctor for Abbott, Biosense Webster, and Boston Scientific. Post ablation, all voltage maps consistently showed extensive antral PV lesions. Figure 4. En Bloc enucleation with early apical release technique using MOSES (En Bloc MoLEP) vs. classic En Bloc HoLEP: a single arm study comparing intra- and postoperative outcomes. A novel preclinical model was created to nonsurgically assess the response to esophageal injury. Author HG received a speaker fee from Biosense Webster. Please enable it to take advantage of the complete set of features!
Pulsed field ablation prevents chronic atrial fibrotic changes and Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations. At 1 year, 81.1% of patients were free from AF. The Globe PF System is an all-in-one solution for treating atrial fibrillation, which affects more than 59 million people worldwide. 9. Four applications were given with the catheter in the basket shape and four additional applications were given in the flower shape. J Cardiopulm Rehabil Prev. Burnaby, BC, November 8, 2022--(T-Net)--Kardium Inc. announced today the successful first-in-human study of its next generation Globe Pulsed Field System to treat atrial fibrillation (AF) using pulsed field ablation (PFA) therapy. Why Should I Register and Submit Results? In all patients (100%), all PVs were confirmed to be isolated. Ablation; Atrial fibrillation; Electroporation; Pulsed field ablation. How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)? Rate of procedural complications. After high-density left atrial (LA) bipolar voltage mapping, all PVs were individually isolated using a 13Fr steerable sheath and a pentaspline PFA over-the-wire catheter. Additionally, we monitored for the occurrence of major and minor complications (see Table 3) but no targeted investigations were carried out for the detection of complications, such as silent gas emboli, PV stenosis, or oesophageal involvement (18). (2017) 14:e275444. According to this legislation, neither obtaining informed consent from patients nor approval by a Medical Ethics Committee is obligatory for this type of observational studies containing no directly identifiable data (Dutch Civil Law, Article 7:458).
Pulsed Field Ablation to Treat Atrial Fibrillation: A Review of the Study record managers: refer to the Data Element Definitions if submitting registration or results information. Working . We observed that PFA is a safe ablation modality with effective acute isolation of the PVs. Figure 1. (2015) 18:717. 2. Accessed May 16, 2021. ABOUT / FARAPULSE A NEW ERA FARAPULSE is the pioneer of a new era in cardiac ablation. Pre-procedural investigations included trans-thoracic echocardiogram (TTE), cardiac computed tomography (CT) scan, electrocardiogram (ECG), and lab work. (2020) 13:e008192. Published by Oxford University Press on behalf of European Society of Cardiology. Pulsed field ablation uses high-frequency electrical pulses to ablate cardiac tissue. Objectives: This study sought to assess the safety and lesion durability of pulsed field ablation (PFA) for both PVI and LAPW ablation in persistent AF. While myocardium is susceptible to irreversible injury, esophagus, phrenic nerves, pulmonary veins and coronary arteries are relatively resistant. The 31 and 35 mm catheters were used in 77% (77) and in 23% (23) of procedures, respectively. Enter your library card number to sign in. We report on possible bronchial injury after PVI using PFA for paroxysmal AF. One day after PVI, bronchoscopy without biopsies was performed. The fast uptake of the correct PFA handling and over-the-wire technique may have been facilitated by the experience operators already possessed with cryoballoon ablation. AF is the most common type of cardiac arrhythmia affecting an estimated . Introduction: Pulsed field ablation (PFA) was recently introduced for the treatment of symptomatic atrial fibrillation (AF) with the claim of selectively ablating the myocardium while sparing surrounding tissues. doi: 10.1016/j.jacep.2021.08.016. Pulsed field ablation in patients with persistent atrial fibrillation. Results: In 121 patients, acute PVI was achieved in 100% of PVs with PFA alone.
Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency Kueffer T, Baldinger SH, Servatius H, Madaffari A, Seiler J, Mhl A, et al. Article. Do not use an Oxford Academic personal account. Major complications included bleeding requiring thoracotomy or transfusion, permanent phrenic nerve paralysis, pacemaker device implantation, stroke/transient ischemic attack, atrio-esophageal fistula requiring surgery, and death. Med., 08 November 2022, View all
Pulsed field ablation (PFA), a non-thermal ablative modality, may show different effects on the myocardial tissue compared to thermal ablation. Ablation of atrial fibrillation with pulsed electric fields: an ultra-rapid, tissue-selective modality for cardiac ablation. Conclusion: Pulsed field ablation induces large acute LGE without microvascular damage or intramural haemorrhage.
Pulsed Field Ablation Treats AF With Few Complications - Medscape November 2022; Frontiers in Cardiovascular Medicine 9 3. In addition, Spearmans rank correlation showed that practice was not correlated with procedure time (Operator 1: correlation coefficient = 0.246, p = 0.283; Operator 2: correlation coefficient = 0.139, p = 0.439). Figure 4 shows the learning curves for Operators 1 and 2 who both performed more than 20 procedures without mapping. Ablative energy is delivered from all electrodes. doi: 10.1016/j.jacc.2020.07.007, 16. All hemoglobin levels remained stable. Bookshelf Adverse safety events occurred in 2.5% of patients (2 pericardial effusions, 1 hematoma, and 1 transient ischemic attack). Table 1 shows the baseline characteristics of the first 100 patients with symptomatic AF who were treated with PFA at our center. Six different operators performed the ablations described in this study: Operator 1 performed 37 procedures (37%); Operator 2 performed 35 procedures (35%); Operator 3 performed 14 procedures (14%); Operator 4 performed six procedures (6%); Operator 5 performed four procedures (4%); and Operator 6 performed four procedures (4%). The site is secure. Kaminska I, Kotulska M, Stecka A, Saczko J, Drag-Zalesinska M, Wysocka T, et al. Post ablation, all voltage maps consistently showed extensive antral PV lesions. Federal government websites often end in .gov or .mil. Thermal-based catheter ablation systems (eg, radiofrequency and cryoablation) are the cornerstone treatment modalities for patients with antiarrhythmic drug resistant, symptomatic paroxysmal, and persistent atrial fibrillation. All patients underwent uncomplicated bronchoscopy, without thermal lesions or ulcers.
Pulsed-Field Ablation for Atrial Fibrillation IntroductionPulsed field ablation (PFA) was recently introduced for the treatment of symptomatic atrial fibrillation (AF) with the claim of selectively ablating the myocardium while sparing surrounding tissues. Pulsed field ablation (PFA) is a novel non-thermal energy source to conduct catheter ablation of atrial fibrillation (AF). This process was repeated for each PV. Published by Oxford University Press on behalf of European Society of Cardiology. Heparin (100 IU/kg) was given prior to transseptal puncture, and the target activated clotting time (ACT) was > 300 s. The PFA system had three components: a custom generator (Farastar, Farapulse) that delivered a high-voltage pulsed field waveform over multiple channels, a PFA catheter (31 or 35 mm diameter), and a 12-F steerable sheath (Faradrive, Farapulse). Mean radiation time and median radiation dose were 14.1 9.6 min and 985.5 (306.21652.1) Gy/m2, respectively. "We are excited to begin the pivotal stage of the PULSED AF study and generate a larger body of clinical evidence to support the safety and benefits of pulsed field ablation." Atrial fibrillation is one of the most common and undertreated heart rhythm disorders, affecting more than 37 million people worldwide.
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed JACC Clin Electrophysiol. Anticoagulation was initiated at least 4 weeks before the procedure and continued for at least 3 months afterward. Copyright 2022 European Society of Cardiology. PAEs include the adverse events like Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction and pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/CVA, thromboembolism, transient Ischemic Attack (TIA).
Initial experience with pulsed field ablation for atrial fibrillation There was no difference between the procedure times between senior and junior operators (Operator 1: 46.9 9.7 min vs. After a guidewire was positioned in the left superior PV, the SL0 sheath was exchanged for the Faradrive (Farapulse, Menlo Park, CA, USA) sheath and the Farawave (Farapulse) catheter was advanced into the left atrium. *Correspondence: Federico T. Magni, f.t.magni@umcg.nl, ORCID: Federico T. Magni, orcid.org/0000-0003-3433-8838; Bart A. Mulder, orcid.org/0000-0002-4411-3918; Hessel F. Groenveld, orcid.org/0000-0002-0284-8553; Ans C. P. Wiesfeld, orcid.org/0000-0003-0285-5881; Robert G. Tieleman, orcid.org/0000-0002-7654-2098; Moniek G. Cox, orcid.org/0000-0003-2825-8428; Isabelle C. Van Gelder, orcid.org/0000-0002-7579-1201; Tom Smilde, orcid.org/0000-0002-9638-7654; Michiel Rienstra, orcid.org/0000-0002-2581-070X; Yuri Blaauw, orcid.org/0000-0003-2366-3686, Atrial Fibrillation: Insights on mechanisms, mapping and catheter ablation, Front.