A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF) (AFIRE)

A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Multi-electrode Circular IRE Catheter and Multi-Channel IRE Generator in Paroxysmal AF

The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).

Study Overview

• Status: Completed
• Conditions: Refractory Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Multi-Channel Irreversible Electroporation (IRE) Generator; Device: Multi-Channel Circular IRE Catheter

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • the First Affiliated Hospital of Zhengzhou University
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai General Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation [AF]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip
• Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD
• Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
• Willing and capable of providing consent

Exclusion Criteria:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity)
• Previous left atrium (LA) ablation or surgery
• Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
• Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
• Severe dilatation of the LA (documented LAD >50 millimeters [mm] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Irreversible Electroporation (IRE) System; Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation will be treated with the IRE system which includes multi-electrode circular IRE catheter and the multi-channel IRE generator.

Device: Multi-Channel Irreversible Electroporation (IRE) Generator; The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy.; Other Names: D-1417-01-I; Device: Multi-Channel Circular IRE Catheter; The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation.; Other Names: D-1412-01-SI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Long-term Effectiveness	Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study.	From Day 91 up to Day 365 post-procedure on Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Primary Adverse Event (PAE)	Percentage of participants experiencing PAE were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. Primary AEs within seven days of the ablation procedure which used investigational devices per protocol, including the initial and repeat procedures were reported. PAEs included cardiac tamponade, perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischaemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, pulmonary vein stenosis, pulmonary oedema (respiratory insufficiency), vagal nerve injury/gastroparesis, pericarditis, major vascular access complication/bleeding, and atrio-esophageal fistula .	Within 7 days post-procedure on Day 0
Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure	Percentage of participants with SAEs within 7 days (early-onset), 8-30 days (peri-procedural) and >30 days (late onset) of initial ablation procedure were reported. A SAE was any adverse event (AE) that resulted in a death or a serious deterioration in the health of the participant during the clinical trial, including a life-threatening illness or injury, a permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a body function; or resulted in fetal distress, foetal death or congenital abnormality, congenital anomaly, etc.	From day of procedure (Day 0) up to 12 months
Percentage of Participants With Acute Procedural Success	Percentage of participants with acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter was considered as acute procedural failure.	On the day of procedure (Day 0)
Percentage of Participants With Acute Reconnection	Percentage of participants with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.	On the day of procedure (Day 0)
Percentage of Pulmonary Veins (PVs) With Acute Reconnection	Percentage of PVs with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant.	On the day of procedure (Day 0)
Percentage of Participants With Pulmonary Vein (PV) Ablation	Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported.	On day of procedure (Day 0)
Percentage of Participants With Repeated Ablation	Percentage of participants with repeated ablation within the 12 months follow up period, including timing (blanking period or after blanking) were reported. Repeat procedures for AF/AT/AFL of unknown origin plus recurrences during the blanking period (90 days post index procedure) were conducted with the investigational device for ablating PV reconnections. Repeat procedures performed after the blanking period were managed per investigator discretion using a commercially available ablation catheter and generator.	From the day of procedure (Day 0) up to 12 months

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Chair: Jianzeng Dong, the First Affiliated Hospital of Zhengzhou University; Principal Investigator: Shaowen Liu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Hailong Tao, the First Affiliated Hospital of Zhengzhou University; Principal Investigator: Hua Fu, West China Hospital; Principal Investigator: Yumei Xue, Guangdong Provincial People's Hospital; Principal Investigator: Heng Cai, Tianjin Medical University General Hospital; Principal Investigator: Lianjun Gao, The First Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): December 18, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Investigative Techniques; Clinical Laboratory Techniques; Cytological Techniques; Equipment and Supplies; Radiation Equipment and Supplies; Electrochemical Techniques; Electroporation; Radionuclide Generators
• Other Study ID Numbers: BWI202107 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes