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: Active, not recruiting
• Conditions: Refractory Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Multi-Channel Irreversible Electroporation (IRE) Generator; Device: Multi-Channel Circular IRE Catheter

• Study Type: Interventional
• Enrollment (Estimated): 147
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: +86 15210099156; Email: yzhan365@its.jnj.com

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
    • Shanghai, Shanghai, China
      • Shanghai General Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, 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
Number of Participants with Long Term Effectiveness Without Antiarrhythmic Drug (AAD) Use	Long term effectiveness is defined as freedom more than or equal to (>=) 30 seconds from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), and atrial flutter (AFL) of unknown origin based on electrocardiographic data during the effectiveness evaluation period.	91-365 days post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Acute Procedural Success	Acute Procedural Success defined as confirmation of entrance block in all clinically relevant targeted pulmonary vein (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter will be considered as acute procedural failure.	Up to 12 months
Number of Participants with Acute Reconnection	Acute reconnection identified by adenosine/isoproterenol challenge. Among all clinically relevant targeted PVs and by subject.	Up to 12 months
Number of Participants with Rate of PV	Rate of PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted PVs and by subject.	Up to 12 months
Number of Participants with Rate of Repeated Ablation	Rate of repeated ablation within the 12 months follow-up period, including timing (blanking period or after blanking) and rate of PV reconnection.	Up to 12 months
Number of Participants with Primary Adverse Events (PAEs)	An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.	Within 7 days of ablation procedure
Number of Participants with Serious Adverse Events (SAEs) Within 7 days, 8-30 Days and More Than 30 Days of Initial Ablation Procedure	An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.	Within 7 days, 8-30 days and more than (>) 30 days of initial ablation procedure
Number of Participants with AEs	An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.	Up to 12 months
Number of Participants with SAEs	An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.	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 (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 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): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• 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