The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)
NCT ID: NCT05400928
Last Updated: 2022-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2021-07-05
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Three-dimensional Directed Pulsed Field Ablation
Paroxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Pulsed Field Ablation
pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Interventions
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Pulsed Field Ablation
pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Left ventricular ejectfraction(LVEF)\<35%
3. Left Atrium(LA)（echocardiography）\>55mm
4. Thrombus in the left atrial or heart before surgery
5. New York Heart Association(NYHA) grade Ⅲ-Ⅳ
6. second or third degree atrioventricular block
7. Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale)
8. Prosthetic valves
9. Pacemakers or defibrillators (ICD)
10. Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
11. Symptomatic carotid stenosis
12. Untreated or uncontrolled hyperthyroidism or hypothyroidism
13. Systemic active infection
14. Renal failure with obvious bleeding tendency or undergoing hemodialysis
15. Myocardial infarction or any cardiac intervention/open surgery within 3 months
16. Stroke or transient ischemic attack within 6 months
17. Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation
18. Pregnant or lactating women or those who planned to have a family during the study period
19. Have participated in clinical trials of other drugs or medical devices within 3 months
20. Unsuitable to participate in this clinical trial by the investigator
18 Years
75 Years
ALL
No
Sponsors
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Jiangxi Provincial People's Hopital
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Central South University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Zhongshan Hospital Xiamen University
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Tongji Hospital
OTHER
Responsible Party
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Dao Wen Wang
Professor
Principal Investigators
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Daowen Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital Wuhan, Hubei China
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Mansour M, Heist EK, Agarwal R, Bunch TJ, Karst E, Ruskin JN, Mahapatra S. Stroke and Cardiovascular Events After Ablation or Antiarrhythmic Drugs for Treatment of Patients With Atrial Fibrillation. Am J Cardiol. 2018 May 15;121(10):1192-1199. doi: 10.1016/j.amjcard.2018.01.043. Epub 2018 Feb 12.
Hakalahti A, Biancari F, Nielsen JC, Raatikainen MJ. Radiofrequency ablation vs. antiarrhythmic drug therapy as first line treatment of symptomatic atrial fibrillation: systematic review and meta-analysis. Europace. 2015 Mar;17(3):370-8. doi: 10.1093/europace/euu376. Epub 2015 Feb 1.
Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky I, Hebeler R, Labrousse L, Barandon L, Kralovec S, Funosako M, Mannuva BB, Sediva L, Neuzil P. Ablation of Atrial Fibrillation With Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation. JACC Clin Electrophysiol. 2018 Aug;4(8):987-995. doi: 10.1016/j.jacep.2018.04.005. Epub 2018 May 11.
Koruth JS, Kuroki K, Iwasawa J, Viswanathan R, Brose R, Buck ED, Donskoy E, Dukkipati SR, Reddy VY. Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation. Europace. 2020 Mar 1;22(3):434-439. doi: 10.1093/europace/euz341.
Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.
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.
Maor E, Sugrue A, Witt C, Vaidya VR, DeSimone CV, Asirvatham SJ, Kapa S. Pulsed electric fields for cardiac ablation and beyond: A state-of-the-art review. Heart Rhythm. 2019 Jul;16(7):1112-1120. doi: 10.1016/j.hrthm.2019.01.012. Epub 2019 Jan 11.
Sugrue A, Vaidya V, Witt C, DeSimone CV, Yasin O, Maor E, Killu AM, Kapa S, McLeod CJ, Miklavcic D, Asirvatham SJ. Irreversible electroporation for catheter-based cardiac ablation: a systematic review of the preclinical experience. J Interv Card Electrophysiol. 2019 Sep;55(3):251-265. doi: 10.1007/s10840-019-00574-3. Epub 2019 Jul 3.
Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3.
Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.
Buist TJ, Adiyaman A, Smit JJJ, Ramdat Misier AR, Elvan A. Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation. Clin Res Cardiol. 2018 Jun;107(6):498-506. doi: 10.1007/s00392-018-1211-9. Epub 2018 Feb 6.
Furnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
Other Identifiers
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JJETCT2021002
Identifier Type: -
Identifier Source: org_study_id
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