The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

Paroxysmal Atrial Fibrillation Clinical Trial

— ESPFA-CN21  

Official title:

The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400928
• Other study ID #: JJETCT2021002
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Tongji Hospital
• Contact: Daowen Wang, PhD
• Phone: 86-72-83662842
• Email: dwwang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)

Description:

This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. For those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (Sichuan Jinjiang Electronic Technology Co., Ltd. Chengdu, China). 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Paroxysmal Atrial Fibrillation (PAF)

Exclusion Criteria:

1. A history of atrial fibrillation ablation;

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 ?-?

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Pulsed Field Ablation
pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (8)

Lead Sponsor	Collaborator
Tongji Hospital	Central South University, Fuwai Central China Cardiovascular Hospital, Jiangxi Provincial People's Hopital, Second Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Dalian Medical University, Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (13)

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. Erratum in: Clin Res Cardiol. 2018 Mar 6;:. — View Citation

Fürnkranz 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. — View Citation

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. Review. — View Citation

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-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. Erratum in: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Erratum in: Eur Heart J. 2021 Oct 21;42(40):4194. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate success rate	Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation	during procedure
Secondary	Procedural success rate at 12 months after procedure	Procedural success for PAF was defined as the absence of atrial fibrillation/atrial flutter/atrial tachycardia (duration =30s) without antiarrhythmic drugs between 3 months and 12 months after ablation	between 3 months and 12 months after ablation
Secondary	The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up	The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up	at 6-month and 12-month
Secondary	Evaluation of pulsed electric field ablation instrument	operational stability; Hardware Connection validity; Software operability; degree of satisfaction	baseline
Secondary	Evaluation of a disposable cardiac pulsed electric field ablation catheter	Whether the catheter can reach its desired location smoothly; X ray and shadow;development is clear; Whether the conduit bend is adjustable; Whether the electrophysiological signal is clear and stable; When used together with the mapping system, whether mapping and 3D modeling can be carried out; When used in conjunction with the mapping system, can the catheter be located; Is it possible to stimulate normally; Whether the ablation can be performed normally; Were there any blood clots after withdrawal; Is the tube body intact after withdrawal from the body; Surgeon satisfaction	baseline